37 Pharmacokinetics Jobs

Job Location: Ahmedabad Job Role for Biostatistician: 1. Provide inputs regarding sample size, study design, randomization and PK-statistical analysis in protocol. 2. Prepare randomization schedule using SAS for the project as per the protocol. 3. Perform and review statistical analysis of pharmacokinetic pharmacodynamic parameters using phoenix WinNonlin or SAS. 4. Prepare summary and final reports for the study. 5. Perform the validation of the SAS codes and softwares used for calculation and analysis of Pharmacokinetic and statistical data. 6. Maintain all necessary records for the reporting phase of the study. 7. Prepare inputs in sample analysis detail Preferred Candidate: M.Sc(Statistics) fresher candidate with basic understanding of BA/BE.

About the Role Responsibilities Patient Preparation & Procedure Execution: Explain procedures to patients and address concerns about radiation exposure. Prepare and position patients for nuclear medicine scans (e.g., bone scan, thyroid scan, PET-CT). Administer radiopharmaceuticals (oral, IV, or inhalation) under supervision. Monitor patients during procedures and observe for adverse reactions. Imaging & Equipment Handling: Operate nuclear imaging systems such as SPECT, SPECT/CT, and PET/CT. Ensure optimal image quality by proper acquisition techniques and equipment calibration. Assist in image processing and transfer to PACS or hospital EMR systems. Radiopharmaceutical Handling: Receive, store, and handle radioactive materials in compliance with AERB guidelines. Measure and prepare accurate doses using dose calibrators and shielding equipment. Dispose of radioactive waste safely and maintain related documentation. Radiation Safety & QA: Use radiation protection equipment (e.g., lead aprons, tongs, shielded syringes). Perform regular QA checks of imaging equipment and radiation monitoring devices. Maintain personnel exposure records using TLD/film badges and ensure area monitoring. Assist the Radiation Safety Officer in implementing AERB-mandated protocols. Record-Keeping & Compliance: Maintain logs of procedures, isotope usage, patient doses, and QA reports. Document any incidents or deviations from standard procedures. Support internal and external audits by regulatory authorities (e.g., AERB). Qualifications Educational Qualification: B.Sc. in Nuclear Medicine Technology OR B.Sc. in Physics/Allied Science + Diploma in Nuclear Medicine Technology (DNMT) Preferably trained at an AERB-recognized institution Experience: 0–5 years of hands-on experience in nuclear medicine scanning and radiopharmaceutical handling Registration / Certification: AERB certification for handling radioactive materials (desirable/mandatory based on jurisdiction) Required Skills Familiarity with nuclear imaging equipment (PET, SPECT, CT) Understanding of radiopharmaceuticals and their pharmacokinetics Strong sense of responsibility and precision in dose measurement Good communication and patient-care skills Knowledge of radiation protection and emergency procedures Pay range and compensation package Salary: As per institutional norms and experience Show more Show less

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Proud to be recognized as one of Forbes' America's Best Startup Employers!Also proud to be recognized as a Most Loved Workplace! Enveda is looking for a Senior Research Associate / Research Associate, Invivo Pharmacokinetic to join our team in Hyderabad, India. The successful candidate will get ample opportunities to shape his/her career as DMPK expert in various activities. The contribution you will make: The successful candidate will provide support and expertise to establish and in-vivo Pharmacokinetics studies, PK data analysis and interpretation followed by be able to provide support at multiple levels for our projects in alignment with the company's strategic goals. As a member of the DMPK team, you will work closely with the in vivo drug metabolism team. You Get To Collaborate On Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals’ surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE. Who will thrive in this role? M.Pharm / M.S in Pharmacology with 3-5 years of research experience in either academic or industrial R&D setting. Deep understanding in pharmacokinetics, physiology along with in vivo disease model development and testing. Prior experience in small animal handling, dosing through different routes of administration, dissections and tissue harvesting, tissue processing Fair understanding about the drug discovery process. Excellent organizational, interpersonal, and problem-solving skills Experience of working with different cross functional teamsExcellent oral and written communication skillsStrong work ethic; scientific curiosity; can-do, will-do attitude. Experience in using electronic lab notebook system. If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience. What To Expect In The Interview Process HR Screen (30 minutes) Work Sample Interview (45 minutes) Technical Interview (45 minutes) Enveda Culture Interview (45 minutes) Some Of The Total Rewards Of Working Here Culture: Enveda lives for people Healthcare: Medical insurance premium for coverage of the employee, spouse, and kids is fully sponsored by the company. The premium for coverage of dependent parents is partially sponsored by the company (at 50%). PTO: Block leaves (that we encourage and celebrate) and company-wide weeklong break to recharge in addition to 8 observed holidays. Work-Life Harmony Come join us! Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you. Employee Promise Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work. Enveda's values Curiosity: Learn and challenge. Agency: Own and initiate. Journey: Love the process. Charity: Take care of each other. Unity: We are one Enveda. We value your uniqueness One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles. Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. One-Enveda is a company value because success depends on trusting, working relationships that respect the commonality and differences of people. At Enveda we are building a place where every person can do the best work of their lifetime. Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws. Please note jobs may be taken down from our website, this does not mean they have been filled. This is to maintain our candidate experience for current applicants. If you are in the interview process and would like to request a copy of the job description, reach out to your recruiting contact. Show more Show less

About the Role The Nuclear Medicine Technician is responsible for preparing and administering radiopharmaceuticals, operating imaging equipment such as gamma cameras and PET/CT scanners, and ensuring patient safety during nuclear medicine procedures. The role requires adherence to strict radiation safety standards and coordination with radiologists and medical physicists for accurate diagnosis and treatment. Responsibilities Patient Preparation & Procedure Execution: Explain procedures to patients and address concerns about radiation exposure. Prepare and position patients for nuclear medicine scans (e.g., bone scan, thyroid scan, PET-CT). Administer radiopharmaceuticals (oral, IV, or inhalation) under supervision. Monitor patients during procedures and observe for adverse reactions. Imaging & Equipment Handling: Operate nuclear imaging systems such as SPECT, SPECT/CT, and PET/CT. Ensure optimal image quality by proper acquisition techniques and equipment calibration. Assist in image processing and transfer to PACS or hospital EMR systems. Radiopharmaceutical Handling: Receive, store, and handle radioactive materials in compliance with AERB guidelines. Measure and prepare accurate doses using dose calibrators and shielding equipment. Dispose of radioactive waste safely and maintain related documentation. Radiation Safety & QA: Use radiation protection equipment (e.g., lead aprons, tongs, shielded syringes). Perform regular QA checks of imaging equipment and radiation monitoring devices. Maintain personnel exposure records using TLD/film badges and ensure area monitoring. Assist the Radiation Safety Officer in implementing AERB-mandated protocols. Record-Keeping & Compliance: Maintain logs of procedures, isotope usage, patient doses, and QA reports. Document any incidents or deviations from standard procedures. Support internal and external audits by regulatory authorities (e.g., AERB). Qualifications Educational Qualification: B.Sc. in Nuclear Medicine Technology OR B.Sc. in Physics/Allied Science + Diploma in Nuclear Medicine Technology (DNMT) Preferably trained at an AERB-recognized institution Experience: 0–5 years of hands-on experience in nuclear medicine scanning and radiopharmaceutical handling Registration / Certification: AERB certification for handling radioactive materials (desirable/mandatory based on jurisdiction) Required Skills Familiarity with nuclear imaging equipment (PET, SPECT, CT) Understanding of radiopharmaceuticals and their pharmacokinetics Strong sense of responsibility and precision in dose measurement Good communication and patient-care skills Knowledge of radiation protection and emergency procedures Pay range and compensation package Salary: As per institutional norms and experience Equal Opportunity Statement [Include a statement on commitment to diversity and inclusivity.] ``` Show more Show less

1. Clinical Trial Design and Oversight, 2. Drug Efficacy and Safety Analysis, 3. Drug Interactions and Adverse Reactions, 4. Research and Development, 5. Compliance and Regulatory Affairs, 6. Patient Counseling, 7. Monitoring Drug

Skills Required JOB DESCRIPTION Basic knowledge in Phoenix WinNonlin® software in creating workflows independently. Demonstrated strong understanding of Drug Discovery and Development, PK/PD principles, physiology/pharmacology and biopharmaceutics through scientific presentations, posters and publications. Thorough knowledge regarding International Conference on Harmonization-Good Clinical Practice. Basic knowledge in using SAS® and R Programming. Basic knowledge in Medical and Scientific writing. Basic Knowledge regarding Clinical Trials Methodologies. Responsibilities Reads and understands the study protocol, PK analysis specifications worksheet, and project requirements. Prepares and understands Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications. Merges concentration-time data and performs data cleaning process. Creates/Reviews Non-compartmental analysis (NCA) workflows in Phoenix WinNonlin® 8.1 or higher. Creates Tables, Listings, and Figures (TLF), and summary reports for regulatory submission. Plays an active role in planning, execution, and delivery of pharmacokinetic assignments ensuring on-time quality deliveries. Prepares and reviews SAS® transport files for regulatory submission. Perform quality control and quality assurance of PK deliverables as per the client assignment specifications. Coordinates cross-functional activities involving statisticians, SAS® programmers, and medical writers involved in pharmacokinetic projects. Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799, and client’s SOPs. Reviews source, outcome database entries (i.e., ensures accurate publication digitization). Qualifications Master of Pharmacy (M. Pharmacy) in Pharmacology/Pharmaceutics/Pharmaceutical technology. 1-2 years of hands-on experience in PK analysis, interpretation and reporting of clinical trials data using Phoenix WinNonlin® software. Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts. Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications. Hands-on experience on Population PK (POP PK) using NONMEM® or Phoenix NLME, Statistical analysis using SAS® and Medical Writing activities would be an added advantage. Should have good academic credits and excellent communication skills (oral and written) About Us Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture. Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit! Show more Show less

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits

We are seeking a dedicated and knowledgeable Senior Resident in Pharmacology to join our healthcare team. The ideal candidate will play a crucial role in advancing pharmacological research and improving patient care through effective drug management and clinical trials. This position is suitable for candidates with 0-1 years of experience in the field. Responsibilities Assist in the development and implementation of pharmacological research protocols. Conduct clinical trials and monitor patient responses to pharmacological treatments. Collaborate with a multidisciplinary team to analyze data and present findings. Participate in patient consultations to provide pharmaceutical care and education. Maintain accurate records of patient interactions, trial results, and research activities. Stay updated with the latest advancements in pharmacology and related fields. Skills and Qualifications MBBS or MD degree with specialization in Pharmacology. Strong understanding of pharmacological principles and drug interactions. Experience with clinical trial protocols and data collection methodologies. Excellent communication skills to convey complex information to patients and team members. Ability to work collaboratively in a multidisciplinary team environment. Proficient in using statistical software for data analysis. Detail-oriented with strong organizational and documentation skills.

Job Description This role is for a full-time Consultant for the Quantitative Pharmacology and Pharmacometrics group (QPP) in Cytel. You will be responsible for non-compartmental pharmacokinetics analyses, QC and programming within QPP. Responsibilities Performing and QC and interpretation of non-compartmental pharmacokinetics (PK) analyses, including data formatting Contribution to the PK portion of Statistical Analysis Plans Interfacing with other departments within Cytel, including PBS and FSP. Meeting with clients, as needed Contributing to reports and slide decks Ensuring all analyses are performed under the appropriate standard operating procedures Archiving of all data and analyses Qualifications B.S. or M.S. in pharmacy, biology, chemistry, data science or a related scientific discipline. 3-5 years' experience in the pharmaceutical industry Basic knowledge of pharmacokinetics Must demonstrate proficiency in R programming Experience with WinNONLIN is strongly preferred Show more Show less

An Assistant Professor of Pharmaceutical Sciences typically combines teaching, research, and service responsibilities within a college or university. They are expected to teach undergraduate and graduate courses in pharmaceutical sciences, conduct research, publish scholarly articles, and supervise student research projects. Additionally, they participate in departmental activities, contribute to curriculum development, and may seek external research funding. Key Responsibilities: Teaching: Delivering lectures, conducting laboratory sessions, and developing course materials for undergraduate and graduate courses in areas like pharmaceutics, biopharmaceutics, pharmacokinetics, and drug delivery. Research: Conducting independent or collaborative research, publishing findings in peer-reviewed journals, and seeking external funding for research projects. Service: Participating in departmental committees, advising students, mentoring other faculty, and representing the college or university in professional organizations. Curriculum Development: Contributing to the development and improvement of existing courses and curriculum. Student Mentorship: Advising undergraduate and graduate students, supervising research projects, and providing guidance on academic and professional development. Qualifications: Education: M. Pharm. (Pharmacology) and Ph.D. in Pharmaceutical Sciences or a related field. Experience: Demonstrated research experience, teaching experience, and potentially postdoctoral research experience. Freshers can also apply. Skills: Strong communication, interpersonal, and organizational skills, along with the ability to work collaboratively and independently. Salary : As Per Norms Job Type: Full-time Pay: ₹50,000.00 - ₹65,000.00 per month Benefits: Health insurance Provident Fund Schedule: Fixed shift Work Location: In person

Summary As a Data Science expert, you will join our Modeling & Simulation Data Science team in the Translational Medicine Unit and help us to unleash the power of data science for drug discovery. You will bring your curious, innovative, and collaborative mindset to effectively harness the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetics (PK) / pharmacodynamics (PD) data generated within our department and master the use of our in-house applications and state-of-the-art machine learning (ML) methods and statistical techniques to accelerate drug design. Our group is growing, and we hope you will join our dynamic, enthusiastic and forward-thinking team! About The Role Key responsibilities Your Responsibilities Will Include, But Are Not Limited To Act as the M&S Data Science representative on drug discovery and lead optimization programs by collaboratively contributing to project team discussions, using dry- and wet-lab data to provide scientific and strategic input to guide decisions such as compound progression and in vivo study prioritization Master and advocate the use of in silico models and in-house tools, applications and data to accelerate and streamline decision making Apply data mining to understand relationships between structure and molecular properties for programs involving small molecules, peptides, RNAs Identify opportunities to create custom, project- or modality-specific in silico models and data strategy, and contribute to their development and implementation Proactively seek opportunities to increase the impact and awareness of M&S Data Science through clear and concise communications with internal and external audiences or various expertise Monitor and stay up to date on developments within the field of AI/ML applied to ADME and PK/PD, and data science methods applied to drug discovery Role Requirements Essential requirements: Advanced degree in life sciences with multidisciplinary background (cheminformatics, bioinformatics, biomedical engineering, AI/ML in drug discovery or life sciences, data science, computational biology, computational chemistry or related field) PhD with 2+ years or MSc with 6+ years of relevant work experience with deep knowledge on drug discovery and development processes Experience in the application of (reproducible) data science methods, tools and practices to drug discovery Strong understanding of statistics, machine learning and deep learning Demonstrated knowledge of data visualization and exploratory analysis Solid skills in programming languages, i.e. Python and R, including software development practices such as version control, testing, documentation, etc. Knowledge of machine learning/deep learning libraries such as scikit-learn, keras or pytorch Excellent communication skills and ability to translate analytical concepts for diverse audience and stakeholders (English is our primary language) Desirable Expertise with discovery-stage PK modeling for small molecule compounds (e.g., relating ADME properties to in vivo PK; scaling of preclinical PK to human) is a plus Experience with generative algorithms and explainable AI Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Aster MIMS Kannur is seeking a dedicated and detail-oriented Pharmacist to join our team. The ideal candidate will play a crucial role in ensuring the safe and effective use of medications for our patients. This position is open to candidates with 0-5 years of experience in the pharmacy field. Responsibilities Dispensing medications accurately and safely to patients. Providing information and advice on the safe use of prescriptions and over-the-counter medications. Monitoring patient health and progress to ensure the effectiveness of medications. Collaborating with healthcare professionals to optimize patient care. Maintaining accurate patient records and medication inventories. Counseling patients on lifestyle changes and health management. Ensuring compliance with regulatory and safety standards. Skills and Qualifications Bachelor of Pharmacy (B.Pharm) or Doctor of Pharmacy (Pharm.D) degree. Valid pharmacist license in India. Strong knowledge of pharmacology and pharmaceutical care. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and manage time effectively. Attention to detail and strong organizational skills. Familiarity with pharmacy management software and electronic health records.

Job title: R&D Data Modeling Manager Associate Location: Hyderabad Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference in patients’ daily lives, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with a strong commitment to developing advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The R&D Data Office serves as a cornerstone of this effort. Our team is responsible for cross-R&D data strategy, governance, and management. We partner with Business and Digital and drive data needs across priority and transformative initiatives across R&D. Team members serve as advisors, leaders, and educators to colleagues and data professionals across the R&D value chain. As an integral team member, you will be responsible for defining how R&D's structured, semi-structured and unstructured data will be stored, consumed, integrated / shared and reported by different end users such as scientists, clinicians, and more. You will also be pivotal in developing sustainable mechanisms for ensuring data are FAIR (findable, accessible, interoperable, and reusable). Position Summary The primary responsibility of this position is to support semantic integration and data harmonization across pharmaceutical R&D functions. In this role, you will design and implement ontologies and controlled vocabularies that enable interoperability of scientific, clinical, and operational data. Your work will be critical in accelerating discovery, improving data reuse, and enhancing insights across the drug development lifecycle. Main Responsibilities Develop, maintain, and govern ontologies and semantic models for key pharmaceutical domains, including preclinical, clinical, regulatory, and translational research Design and implement controlled vocabularies and taxonomies to standardize terminology across experimental data, clinical trials, biomarkers, compounds, and regulatory documentation Collaborate with cross-functional teams including chemists, biologists, pharmacologists, data scientists, and IT architects to align semantic models with scientific workflows and data standards Map internal data sources to public ontologies and standards to ensure FAIR (Findable, Accessible, Interoperable, Reusable) data principles Leverage semantic web technologies and ontology tools to build knowledge representation frameworks Participate in ontology alignment, reasoning, and validation processes to ensure quality and logical consistency Document semantic assets, relationships, and governance policies to support internal education and external compliance Deliverables Domain-specific ontologies representing concepts such as drug discovery (e.g., compounds, targets, assays), preclinical and clinical studies, biomarkers, adverse events, pharmacokinetics / dynamics, mechanisms of action, and disease models built using OWL/RDF and aligned with public standards Controlled vocabularies & taxonomies for experimental conditions, cell lines, compound classes, endpoints, clinical trial protocols, etc. Semantic data models supporting the integration of heterogeneous data sources (e.g., lab systems, clinical trial data, external databases) Knowledge graphs or knowledge maps for semantic integration of structured data from internal R&D systems Mappings to public ontologies, standards, and external knowledge bases like: CDISC, MedDRA, LOINC, UMLS, SNOMED CT, RxNorm, UniProt, DrugBank, PubChem, NCBI Ontology documentation & governance artifacts, including ontology scope, design rationale, versioning documentation, and usage guidelines for internal stakeholders Validation reports and consistency checks, including outputs from reasoners or SHACL validation to ensure logical coherence and change impact assessments when modifying existing ontologies Training and stakeholder support materials: slide decks, workshops, and tutorials on using ontologies in data annotation, integration, and search Support for application developers embedding semantic layers About You Experience: 5+ years of experience in ontology engineering, data management, data analysis, data architecture, or another related field Proven experience in ontology engineering, Proven experience in ontology development within the biomedical or pharmaceutical domain Experience working with biomedical ontologies and standards (e.g., GO, BAO, EFO, ChEBI, NCBI Taxonomy, NCI Thesaurus, etc.) Familiarity with controlled vocabulary curation and knowledge graph construction. Demonstrated ability to understand end-to-end data use and business needs Knowledge and/or experience of Pharma R&D or life sciences data and data domains. Understanding of FAIR data principles, data governance, and metadata management Strong analytical problem-solving skills. Demonstrated strong attention to detail, quality, time management and customer focus Excellent written and oral communication skills. Strong networking, influencing, and negotiating skills and superior problem-solving skills Demonstrated willingness to make decisions and to take responsibility for such. Excellent interpersonal skills (team player) Knowledge and experience in ontology engineering and maintenance are required. Knowledge and experience with OWL, RDF, SKOS, and SPARQL Familiarity with ontology engineering tools (e.g., Protégé, CENtree, TopBraid Composer PoolParty), Familiarity with ontology engineering methodologies (e.g., NeOn, METHONTOLOGY, Uschold and King, Grüninger and Fox, etc.) Knowledge and experience in data modeling are highly desired. Experience with pharma R&D platforms, requirements gathering, system design, and validation/quality/compliance requirements Experience with hierarchical data models from conceptualization to implementation, bachelor’s in computer science, Information Science, Knowledge Engineering, or related; Masters or higher preferred Languages: English null Show more Show less

Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad

Summary The Principal Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision. Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level. About the Role Major Accountabilities:- 1. Study level: a. Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and exe-cution of exploratory analyses, and/or PK, PK/PD analyses, exploratory bi-omarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician. b. Explain statistical methodology and interpret analysis results. Provide statisti-cal expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. c. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, confer-ences, scientific meetings. d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials. e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifi-cations for actions/decisions/statements as required. f. Establish and maintain sound working relationships and effective communica-tion within the Clinical Trial Team and Biostatistics & Pharmacometrics team. g. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. 2. Project level: a. Contribute to project level activities as needed. b. Contributes to project team preparation for HA Advisory Committees and meetings. 3. Franchise or Global Line Function level: Contribute to initiatives at global line function level 4. Enterprise level: a. Participate in non-clinical project activities as needed b. Contribute to the review and implementation of health authority guidance c. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings 5. External level: a. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. b. Represent Novartis in statistical discussions at external congresses, confer-ences, scientific meetings. 6. People Management: Mentor new hires and/or junior Statisticians Minimum Requirements: 1. Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives. 2. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives. 3. Experience in Franchise/Therapeutic Area and/or regulatory activities desirable. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

The candidate will undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion of the training, they will be placed for full-time patent analysis in the pharmaceutical domain. Required Candidate profile Scientific and Analytical Thinking Eager to work in drugs and formulation Candidates must have sound knowledge about the subjects they study in Graduation

We Are Hiring - International Sales Specialist – Life Sciences Online Education Experience: Minimum 6 to 8 Years Industry: Education / E-Learning / EdTech Joining: Immediate Joiners Preferred Company: YesM Pharma Job Description: We are a US-based online education provider offering specialized courses in Life Sciences, including Pharmacology, Pharmacokinetics & Pharmacodynamics, Signal Detection, Clinevo database training, and Clinical Trial Management. We are looking for a results-driven International Sales Specialist to promote our courses to foreign medical doctors and healthcare professionals. The ideal candidate should have a solid background in international education or healthcare sales, with an understanding of life sciences or medical training. Key Responsibilities: Drive international sales for online Life Sciences training programs Generate leads, pitch services, and convert prospects across the USA, UK, and Middle East markets Conduct virtual presentations and follow-ups with individual Build and maintain long-term relationships with foreign medical professionals and clients Maintain CRM and sales reporting tools with updated pipeline and progress Coordinate with academic and marketing teams for campaign execution Desired Candidate Profile: 6–8 years of international sales experience (preferably in education, training, or healthcare industry) Strong exposure to USA, UK, and Middle East markets Excellent English communication skills (spoken and written) – must be able to engage fluently with foreign clients Background in Life Sciences, Pharmacy, or Medical domain is a strong advantage Familiar with CRM tools and remote sales practices Must be comfortable working USA shift hours Only candidates with relevant international B2B/B2C sales experience will be considered. Mail CV - pankaj@marketingpanthers.com Show more Show less

Position You will play a critical role in ensuring the safe and effective use of medications for all patients at AHI. The role involves reviewing medication appropriateness, monitoring drug interactions, detecting and analyzing adverse drug reactions, and conducting prescription audits. You will work closely with physicians and other healthcare professionals to adjust doses, monitor restricted antibiotic use, and ensure compliance with hospital policies and standards such as JCI and NABH. Key Responsibilities Conduct daily morning rounds for all in-patient department (IPD) patients and review prescriptions in wards and ICUs before dispensing Lead the prescription audit team, ensuring thorough reviews and compliance with hospital policies Collaborate with doctors to adjust doses for patients with abnormal pharmacokinetics and pharmacodynamics, particularly in cases of renal and hepatic impairment Monitor restricted antibiotic use and coordinate with the infection control officer for the antibiotic stewardship program Prevent, anticipate, and investigate potential drug interactions and adverse drug reactions, presenting monthly reports on these issues to the quality department Monitor and implement the hospital’s narcotic policy, ensuring compliance Regularly check and verify the contents of crash carts and disaster kits Oversee blood sugar monitoring for all IPD patients and ensure timely incident reporting for any major incidents Provide daily reports on medication errors, adverse drug reactions, incomplete prescriptions, dispensing errors, and patient counseling sessions Ensure proper drug information is provided to both doctors and patients, with detailed counseling during patient discharge Conduct training sessions for ward and ICU pharmacists and nurses, keeping them up to date with clinical practices Coordinate and organize meetings for the Therapeutic Committee, maintain minutes, and follow up on action items Regularly update the hospital’s drug formulary, ensuring compliance with storage regulationsand monitor medication expiry dates Maintain room and refrigerator temperatures according to FDA regulations Monitor medication appropriateness, conducting audits, and ensuring safe and effective drug use according to JCI and NABH standards Qualifications Either Masters or Doctor of Pharmacy (Pharma D) is required Minimum 2 years experience About Asian Heart Institute Asian Heart Institute is India's #1 cardiac hospital dedicated to incorporating the latest technological advances and ethical practices to provide quality heart care at reasonable costs. As a JCI, NABH, and ISO-accredited hospital with a staggering success rate of 99.83% in bypass surgeries and an overall 99.4% in cardiac surgeries, we are considered among the best globally. Our foundation rests firmly on four core pillars: Ethics, Experience, Excellence, and Expertise. At the heart of our approach is a steadfast commitment to integrity and ethical practices, ensuring that every patient is treated with the highest level of respect and care. We take pride in our team of renowned experts, each contributing years of specialized experience and skill, which is pivotal in driving our pursuit of excellence. Our focus on expertise is not just about having the best professionals on board, but also about fostering continuous learning and staying ahead in our field. Powered by JazzHR UMXeBeKYEz Show more Show less

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description As part of the Clinical Development team at Azurity, the Clinical Development Manager, is primarily responsible for supporting departmental activities including but not limited to clinical trials (phase 1 to phase 4), conducting targeted scientific analyses for projects across therapeutic areas for nonclinical and clinical programs at Azurity. In this role, the candidate will report to the Associate Director, Clinical Development. Principle Responsibilities This should specifically outline, in bullet form, the responsibilities of the job: Ability to understand integrated data (formulation, pharmacokinetics/genomics, pharmacodynamics, pharmacovigilance, etc.) from clinical trials, treatment guidelines, and other resources to provide scientific evaluations and develop risk assessments. Provides operational and scientific oversight of nonclinical and clinical studies from study design to study closeout ensuring GCP/ICH/regulatory compliance of study documents, processes and procedures. Author study documents, including protocols, consents, management plans, amendments, etc. Review of CRO/3rd party documents (e.g., SOPs, CRFs, EDC, TFLs, etc.) to ensure alignment with Azurity’s quality expectations and SOPs, if needed. Drafting responses to competent authorities or ethical committees. Vendor and site monitoring. Identify logistical/scientific/ethical/regulatory hurdles/risks and propose solutions. Provide clinical updates on assigned programs. Identify key scientific sources/findings to support clinical development contributions to regulatory communications (e.g., meeting requests, briefing books, IND/NDA submissions, annual reports, etc.) Identify KOLs, external experts/consultants across diverse therapeutic areas to contribute to clinical development objectives. Draft abstracts, posters, oral presentations, and manuscripts. Contribute to process improvement initiatives within clinical development or in collaboration with other functions. Facilitate contractual requirements (CDAs, MSAs, etc.) for clinical development projects in collaboration with applicable Azurity functions. Collaborate with PM function to ensure visibility of project deliverables. Qualifications And Education Requirements This section should include relevant qualifications and education requirements. Degree in scientific/life-sciences field, Master’s degree preferred. 3+ years of experience in clinical development or related role within the pharmaceutical, biotechnology or CRO industry. Working knowledge of clinical research, GCP, GLP, ICH, and FDA regulations. Understanding of pharmaceutical drug lifecycle preferred. Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely. Exceptional analytical and problem-solving skills. Experience in analysis of research data and publications. Demonstrates passion for research and willingness to learn. Brings innovation and creativity to challenging projects. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less

Summary The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. About The Role Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions & Documentation (S&D) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology. Commitment to Diversity & Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Join our dynamic and innovative global Computer-Aided Drug Discovery (CADD) group, now expanding to India! Be a part of our Hyderabad team, where we unite diverse talents to revolutionize the validation and development of new targets in Biomedical Research. As a driving force behind drug discovery, we are excited to find an exceptional computational scientist like you to join our global ranks. Imagine the opportunity to unlock hidden knowledge and disruptive insights from the vast and invaluable data collected by one of the worlds most renowned pharmaceutical companies. We need your expertise, experience, and unwavering passion to help us extract this wealth of information. Collaborating with a multidisciplinary group of scientists, you will be at the forefront of crafting inventive solutions to the most pressing drug discovery challenges, forging new paths toward groundbreaking medicines. Are you'ready to seize this extraordinary chance to make a significant impact in the field of drug discoveryWe invite you to embark on this thrilling journey with us, as we push the boundaries of whats possible in scientific exploration. Join our team and be part of a revolution that will shape the future of medicine. Together, we will transform the landscape of drug discovery, accelerate breakthroughs, and change lives. Apply now and let your expertise shine in our dynamic and forward-thinking environment. About the Role Your Responsibilities Include : Drive the design of medicinal chemistry efforts by applying in-depth knowledge of structure-activity relationships (SAR), a profound understanding of target biology, and predictive methods for assessing on- and off-target activity, physical properties, pharmacokinetics / pharmacodynamics (PK/PD), and synthetic feasibility. Thrive at the intersection of experimental and groundbreaking digital technologies, with a particular emphasis on expertise in machine learning and artificial intelligence (AI) as applied to small molecule drug discovery. Stay abreast of scientific literature and engage with internal and external scientists to incorporate biological insights into lead characterization and screening initiatives. Collaborate with interdisciplinary project teams to facilitate effective decision-making throughout the target identification to candidate nomination process. This involves applying and developing predictive models based on high-content and time-resolved screening data, including imaging techniques. Drive hypothesis generation to enhance clinical success rates for programs involving small molecules, peptides, RNAs, protein degradation, molecular glues, transient covalent inhibitors, and kinetic stabilization of drug-target complexes. Take a leading role in cross-disciplinary mechanistic studies using physics-based modeling and simulation, biophysical characterization, and cellular validation. These studies will inform the strategic targeting strategies of discovery projects, aiming for optimal mechanisms of action (MoAs). Minimum Requirements: Advanced degree in medicinal chemistry, computational chemistry, computational biology, computational chemical biology, or a related field. Candidates with a laboratory-based background in chemistry and biology, supplemented with strong computational experience, are also encouraged to apply. 5+ years of experience working with project teams in a drug discovery environment. Proven track record of innovation through analogue design, leading to significant impact on discovery projects. Familiarity with drug design tools and high-performance computing environments and strong publication history in peer-reviewe'd journals. Skills and Abilities: Proactively anticipates project needs with a clinical focus. Demonstrates rigor and diligence in idea substantiation, analogue design, and experimentation. Strong team orientation with multitasking and adaptability in support and leadership roles. Effective listener with excellent written and oral communication skills. Proficient in data visualization to effectively communicate insights.

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics

As a Data Science expert, you will join our Modeling Simulation Data Science team in the Translational Medicine Unit and help us to unleash the power of data science for drug discovery. You will bring your curious, innovative, and collaborative mindset to effectively harness the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetics (PK) / pharmacodynamics (PD) data generated within our department and master the use of our in-house applications and state-of-the-art machine learning (ML) methods and statistical techniques to accelerate drug design. Our group is growing, and we hope you will join our dynamic, enthusiastic and forward-thinking team Your responsibilities will include, but are not limited to: Act as the MS Data Science representative on drug discovery and lead optimization programs by collaboratively contributing to project team discussions, using dry- and wet-lab data to provide scientific and strategic input to guid e decisions such as compound progression and in vivo study prioritization Master and advocate the use of in silico models and in-house tools , applications and data to accelerate and streamline decision making Apply data mining to understand relationships between structure and molecular properties for programs involving small molecules, peptides, RNAs Identify opportunities to create custom, project- or modality-specific in silico models and data strategy , and contribute to their development and implementation Proactively seek opportunities to increase the impact and awareness of MS Data Science through clear and concise communications with internal and external audiences or various expertise M onitor and stay up to date on developments within the field of AI/ML applied to ADME and PK/PD, and data science methods applied to drug discovery Essential requirements: Advanced degree in life sciences with multidisciplinary background (cheminformatics, bioinformatics, biomedical engineering, AI/ML in drug discovery or life sciences , data science , computational biology , computational chemistry or related field ) PhD with 2+ years or MSc with 6+ years of relevant work experience with deep knowledge on drug discovery and development processes Experience in the application of (reproducible) data science methods , tools and practices to drug discovery Strong understanding of statistics , machine learning and deep learning Demonstrated knowledge of data visualization and exploratory analysis Solid skills in programming languages, ie Python and R, including software development practices such as version control, testing, documentation, etc . Knowledge of machine le a rning/deep learning libraries such as scikit-learn, keras or pytorch Excellent communication skills and ability to translate analytical concepts for diverse audience and stakeholders (English is our primary language) Desirable : Expertise with discovery-stage PK modeling for small molecule compounds (eg, relating ADME properties to in vivo PK; scaling of preclinical PK to human) is a plus Experience with generative algorithms and explainable AI Languages : English.

The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions Documentation (SD) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements: PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement: Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology