89 Pharmacokinetics Jobs - Page 3

Location Bengaluru, Karnataka, India Job ID R-229521 Date posted 24/06/2025 Job Title: Senior Scientist, Clinical PBPK Modeling Introduction to role: Are you ready to dive into the world of pharmacokinetics and translational modeling? As a Senior Scientist in Clinical PBPK Modeling, you'll be at the forefront of implementing innovative and quantitative approaches to propel clinical drug development. Your role will involve conducting mechanistic PBPK using clinical data to support the advancement of drug candidates across various therapy areas. You'll also have the chance to contribute to broader areas within Clinical Pharmacology & Quantitative Pharmacology (CPQP), guided by your experience, interests, and expertise. Are you excited to make a difference? Accountabilities: Apply physiologically-based pharmacokinetic (PBPK) and translational modeling tools to enable clinical PK projections for drug-drug interactions (DDIs), pediatric and specific populations, and other clinical development questions. Collaborate with Drug Metabolism and Pharmacokinetic (DMPK) Scientists and Clinical Pharmacology scientists to generate these mechanistic models. Validate the mechanistic models to the level of being able to be used in Regulatory submissions and to influence the design of clinical trials. Communicate clearly and effectively both internally and externally on topics related to PBPK clinical DDI and pediatric and other specific populations predictions. Keep up to date with emerging literature, modeling science, and regulatory expectations. Essential Skills/Experience : Knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD). Demonstrated broad translational development expertise and experience exemplified by 0-4 Years of drug development experience, with emphasis on PBPK modelling. Good knowledge in pharmacology, drug targets and core disease areas. Demonstrated ability to identify, develop and implement PBPK activities at a project level. Good oral and written communication skills. Good knowledge of global regulatory, compliance, processes, standards and issues specific to PBPK. PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required. Relevant regulatory experience (written). Training and experience with PBPK and other relevant software (e.g., SimCYP, GastroPlus, PK-Sim, Phoenix WinNonlin). Fluency in spoken and written English language. Desirable Skills/Experience: A reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology. Experience in early and late stage drug development. When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world. At AstraZeneca, curiosity drives us to explore what science can achieve. We are committed to making a difference by treating, preventing, modifying, and even curing some of the world's most complex diseases. Our passion for science is fused with data and technology to achieve breakthroughs that redefine possibilities. We celebrate successes and learn from failures as we push boundaries to deliver life-changing medicines. With a diverse team united by shared values, we demonstrate global knowledge to create swift impacts on disease. Here, lifelong learning is encouraged, offering opportunities for growth in an environment where exploration thrives. Ready to make an impact? Apply now and join us on this exciting journey! Date Posted 25-Jun-2025 Closing Date AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. ]]>

We are seeking a highly skilled Biostatistician to join our team in Hyderabad. In this role, you will provide expert support and functional and technical knowledge to ensure the scientific integrity and validity of clinical development, early development, and/or research projects. You will play a crucial part in the full lifecycle of producing key data and reports, from evaluating requirements to coordinating validation and providing quantitative analytical support. This position also involves providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. You may also contribute statistical expertise to research or other R&D areas. Additionally, you'll be responsible for advising and leading the planning, development, and implementation of industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. You will provide expert support and stellar customer focus to business users and teams on their use of various data-related tools and processes. About the Role: Key Responsibilities Study Level Responsible for all statistical tasks on assigned trials, performing mid- to high-complexity trials independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, and reporting activities. Contribute to planning and execution of exploratory analyses, PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial designs 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, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions, explaining statistical concepts clearly to non-statisticians and providing 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. Ensure 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, representing Biostatistics and Pharmacometrics as part of the development plan with oversight. Collaborate with clinical, regulatory, and other strategic functions to drive quantitative decision-making in assigned indications/programs 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 contribute to project team preparation for Health Authority (HA) Advisory Committees and meetings. Franchise or Global Line Function Level Significantly contribute to initiatives at the 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 acceptance of innovative methods within and outside the organization, 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, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Role Requirements MS (in Statistics or equivalent) with 7+ years of relevant work experience OR PhD (in Statistics or equivalent) with 3+ years of relevant work experience . Fluent English (oral and written) with good communication and presentation skills. Ability to influence decisions that directly impact the trial/project and team's 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 modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in the 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. Adherence to good business ethics.

PMS College of Dental Sciences & Research is looking for Asst Proffesor - Pharmacology to join our dynamic team and embark on a rewarding career journey Develop and deliver high-quality lectures and instructional materials. Conduct research and publish findings in academic journals. Advise and mentor students on academic and career matters. Participate in academic committees and contribute to curriculum development. Stay current with developments in the field and incorporate them into teaching.

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 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. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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 Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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 Commitment to Diversity and Inclusion: Accessibility and accommodation 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:

Job Description: Assistant Professor Pharmacy Position: Assistant Professor Pharmacy Department: Pharmaceutical Sciences Location: Rama University , Mandhana Job Type: Full-Time. Position Overview: Rama University ,Kanpur is seeking a dedicated, motivated, and passionate individual to join our faculty as an Assistant Professor in the Department of Pharmacy. The successful candidate will have a minimum of 3 years of teaching experience in pharmaceutical sciences or related fields. This position offers an opportunity to contribute to the academic, research, and clinical education of future pharmacists, while advancing the department's goals and fostering innovation in pharmaceutical education. Key Responsibilities: Teaching: Deliver undergraduate and/or graduate-level courses in the field of pharmacy (Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmaceutical Chemistry, etc.). Develop course materials, including syllabi, assignments, and assessments. Foster a positive learning environment that promotes student engagement and success. Mentor and advise students on academic and career-related matters. Contribute to the development of new curriculum and educational programs. Research: Conduct and publish research in pharmaceutical sciences or related areas. Secure external funding for research projects through grants and other funding opportunities. Supervise and mentor graduate students in research. Service: Participate in departmental, university, and community service activities. Contribute to the development of academic policies and programs within the department. Serve on academic committees and engage in continuous professional development. Qualifications: Education: Ph.D. in Pharmacy, Pharmaceutical Sciences, Pharmacology, or a related field. Candidates with a Pharm.D. and additional research experience may also be considered. Experience: A minimum of 3 years of teaching experience at the university level, preferably in a pharmacy-related field. A demonstrated record of research and scholarly activity. Skills: Strong communication and interpersonal skills. Ability to engage and motivate students in a classroom setting. Proficiency in using modern teaching technologies and learning management systems. Ability to work collaboratively with colleagues, students, and external partners. Preferred Qualifications: Experience in curriculum development and course design. A track record of research publications in peer-reviewed journals. Experience with securing research funding.

Role & responsibilities Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates. Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements. Submit final compilation signed report with e-CTD to client. Co-ordinate with Project Manager for report requirement, sponsor's comments & response. Draft final report and submit to sponsors via project manager. Co-ordinate with BR for bio analytical report and stat for statistical report and submit sponsors via project manager.

Job Title: Good Clinical Practice (GCP) QA Reports To: Associate Director/Director- GCP QA Employment Type: Full-time Workplace Type: Remote Timings: Flexible (Upto 2 am IST, few times a week) Travel : International Travel Required (15-45 days duration) THE CELITO TEAM The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. JOB OVERVIEW We are seeking a highly skilled and experienced Senior Manager or Manager of Good Clinical Practice (GCP) Quality Assurance to join our team. This role is responsible for conducting GCP audits, providing consultations, and supporting clinical trial activities for our Research and Development (R&D) division. This role will involve strategic planning and implementation of GCP principles, supporting inspection readiness activities, and leading the Quality Management System (QMS) initiatives. The ideal candidate will possess significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department. KEY RESPONSIBLIITIES Conduct GCP Audits and Provide Consultations: • Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management. • Offer expert consultations and clinical trial support to R&D teams. Serve in an Advisory Role for R&D: • Advise Clinical Operations, Clinical Development, Statistics, Programming, Regulatory Affairs, Pharmacovigilance, and other R&D functions. • Review and provide feedback on clinical documents including protocols, consent forms, monitoring plans, and data management plans. Quality Assurance Activities: • Oversee quality assurance activities related to clinical, bioanalytical, diagnostic, safety, and pharmacokinetics analyses of clinical studies. • Ensure all activities comply with GCP guidelines and regulatory requirements. Lead GCP Inspection Readiness Activities: • Prepare for and lead GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections. • Develop and implement strategies to maintain continuous inspection readiness. Decision Making on Clinical Quality Matters: • Exercise significant decision-making authority on clinical quality matters, including addressing serious GCP breaches. • Provide guidance and recommendations for resolving quality issues. Support Quality Management System (QMS): • Author and review Clinical Quality Assurance (CQA) Standard Operating Procedures (SOPs). • Review and ensure alignment of functional area SOPs with GCP and regulatory standards. Collaboration and Communication: • Work closely with cross-functional teams to ensure alignment and compliance with GCP. • Provide training and mentorship to team members on GCP and quality assurance practices. Continuous Improvement: • Identify areas for improvement in clinical processes and practices. • Develop and implement corrective and preventive actions (CAPAs) to enhance quality and compliance. Leverage International Experience: • Utilize extensive experience working with US and European companies to navigate and comply with varying regulatory requirements. • Facilitate global clinical trials and ensure adherence to multinational GCP standards. QUALIFICATIONS • Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Medicine). An advanced degree is preferred. • 12- 15 years of experience in clinical research quality assurance or a related field. • Extensive knowledge of GCP guidelines and regulatory requirements. • Proven experience in conducting GCP audits and inspections. • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Ability to work independently and as part of a multidisciplinary team. • Certification in GCP or related areas is a plus. • Extensive experience working with US and European companies. Show more Show less

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