176 Drug Development Jobs - Page 4

Your Key Responsibilities: Your responsibilities include, but not limited to: Technical Support to internal Manufacturing Sites and CMO s: As a Technical Expert to the assigned manufacturing site internally or CMO, ensure and improve product process capability, to keep the knowledge of process up to date and to maintain the product in constant state of validation. Implement Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced. Ensure the availability of all relevant Technical Documentation such as protocols, reports, Risk Assessments, Concept papers, Scientific Justifications based on significant body of information generated regarding the product &...

Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. Management TrackLead a team for the development of pharmaceutical/biological/cell gene therapies working in a small manufacturing plant environment. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans. SANDOZ: Associate Scientist: Design, plan, perform, interpret and report r...

Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads an...

Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise...

Our client, a venture-backed biotech startup focused on developing high-potential therapeutic assets from India with global relevance, is seeking a Chief Scientific Officer (CSO) to join their innovative team. As the CSO, you will collaborate closely with the founder-CEO and the Scientific Advisory Board (SAB) to drive preclinical programs, asset translation, and scientific credibility for investors. This full-time role, based in Bangalore or Hyderabad, offers a competitive salary and significant equity options, aligning your contribution with the company's success. Your key responsibilities will include leading preclinical and IND-enabling studies, aligning scientific plans with strategic g...

You have a strong interest in clinical research and drug development. You have a basic understanding of Good Clinical Practice (GCP) and clinical trial processes (training will be provided). Your attention to detail, communication, and organizational skills are excellent. You have the ability to manage time effectively and work in a team environment. You will support the initiation, monitoring, and close-out of clinical trial sites under supervision. You will also help ensure that sites comply with protocols, GCP guidelines, and regulatory requirements. This is a Full-time, Permanent, and Fresher job opportunity. The benefits include paid sick time. The work schedule is during the day shift....

About Us The Apeejay Stya University is a seat of global learning that offers rich opportunities for innovative teaching-learning, creativity and research across disciplines. It aims to bring about transformation of the society through value-based education, man-making and nation-building by blending together the dual identities of a technology and research-based university with a liberal arts institution. Established by the Apeejay Stya Education Foundation in the state of Haryana [under Act No. 10 of the Haryana Private Universities (Amendment) Act 2010], the ASU provides students not only 'education for living and livelihood' but also 'education for life' and empower learners with a funda...

Are you ready to make a significant impact in the world of Biopharma Clinical Operations As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge Design, develop, implement, maint...

As a Pharmacology Research Lead, you will be responsible for overseeing and managing pharmacological research projects from their initiation to completion. Your role will involve designing and conducting experiments to assess the efficacy and safety of drugs, as well as analyzing pharmacokinetic and pharmacodynamic data to guide drug development processes. You will also be tasked with developing dosage forms and delivery mechanisms for specific therapeutic areas and collaborating with interdisciplinary teams to enhance research methodologies. In addition to conducting research activities, you will be expected to prepare and deliver comprehensive reports on research outcomes, ensuring complia...

As the Oncology Senior Director Disease Area Lead at GSK, you will play a pivotal role in driving the global strategy for clinical operations within your assigned portfolio. You will ensure operational excellence, accelerate development timelines, and optimize delivery to support GSK's mission of improving health outcomes worldwide. In this role, you will lead a high-performing global team of Clinical Operations Asset Leads and Associate COALs, setting the strategic vision and operational direction for delivering the disease area portfolio including Early Phase strategy and delivery for the Disease Area. You will contribute to the Business Development strategic input by providing leadership,...

Working with Us Challenging. Meaningful. Life-changing. Those aren&apost words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You&aposll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We o...

Masters or PhD in Life Sciences, Pharmacy, Bioinformatics, Biomedical Engineering, or related field. 10-15 years of experience in Pharma IT, Life Sciences IT, or Bio IT, with strong exposure to both: Software product development (as product owner, architect, or program leader) IT services delivery (project/program management, client solutions, account growth) Deep understanding of drug development, clinical trials, pharmacovigilance, regulatory affairs, and digital health ecosystems. Demonstrated ability to launch and scale commercial products or platforms for regulated life sciences environments. Proven track record of delivering enterprise software solutions or IT services to global pharma...

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with. The opp...

Safety Analyst (Intern) **Good communication is must This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: Plays an essential role supporting PV Operational Delivery to facilitate and meet client project...

Job Posting Title : External Operations Manager (Distribution) Job Description Summary : The External Operations Manager (EOM) is responsible for operational execution of clinical distribution with the focus on the external part of the clinical trial distribution supply chain. The EOM Distribution oversees all outsourcing activities related to clinical distribution and functions as the key business partner interface with external vendors and ensures operational excellence within the CMO network, ensuring the delivery of high productivity, quality and cost effectiveness. Has operational end to end responsibility for assigned activity. Leads and manages all project and glob-al distribution net...

Key Tasks & Responsibilities: The IRT Project Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Project Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinic...

Summary Location: Mumbai / Hyderabad, India Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About The Role: As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning. You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be ...

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

Required skills : - Experience in computational biology and bioinformatics related areas is a must. - MS/PhD in Bioinformatics, Biostatistics, Mathematics, Computer Science, Computational biology or similar, with a strong publication record. - A strong understanding of statistical principles behind the current best practices in computational biology - Experience in computational biology and bioinformatics related areas is a must. - A strong understanding of statistical principles behind the current best practices in computational biology - Proven experience in drug discovery and development is essential preferably in industrial setting - Expertise in the use of a high-level programming langu...

The Associate Medical Expert in Translational Clinical Oncology (TCO) plays a crucial role as the medical leader for various global studies, roll-over studies, long-term follow-up studies, and studies in the close-out phase. Working under the guidance of a Clinical Program Leader (CPL) and/or Medical Expert, you will provide essential medical support for assigned aspects of active TCO studies. TCO is a department within the Biomedical Research division that focuses on designing and conducting early phase clinical studies in cancer patients, aiming to develop innovative treatments for oncology conditions and bridge the gap between drug discovery and late-phase clinical development. In this ro...

Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities. Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists on medical aspects of drug safety. Review and provide medical, safety input on all required safety reports, including but not limited to: Periodic Safety Update Reports (PSURs) Periodic Benefit Risk Assessment Reports (PBRERs) Periodic Adverse Drug Experience Reports (PADERS) Risk Management Plans (RMPs) Benefit Risk Assessment Signal Evaluation Reports (SERs) Clinical Overview (COs) Clinical Expert Statements Investigator notification letters Author and review aggregate reports for medical context and consistency per ...

Safety Monitoring: Oversee the clinical safety of projects/products, including literature reviews, individual case evaluations, and signal detection. Address safety-related queries promptly and appropriately. Medical Assessment: Conduct medical assessments for single cases, including follow-up information collection, evaluation of product quality defects with adverse events, and preparation of investigator notifications and ethics committee reports. Signal Detection: Identify and evaluate safety signals based on single cases and aggregate data using appropriate tools. Regulatory and Legal Support: Provide medical input for responses to regulatory inquiries, health care professionals, and leg...

Date: 5 Aug 2025 Location: Bangalore, KA, IN, 560100 Custom Field 1: Essential Functions Job Title: Group Leader -GCP QA (Clinical) Job Description Job Title : Group Leader GCP -QA (Clinical) Job Location : Bangalore About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spiri...

The Group Leader -GCP QA (Clinical) at Syngene in Bangalore is responsible for managing the GCP QA auditors team and conducting various audits related to clinical research, process audits, Investigational Site audits, and safety database audits. The role involves assessing systems and practices to improve the GCP Quality System practices in alignment with the national and international GCP Quality System standards. The Group Leader must ensure compliance with quality (GxP) regulations and standards, making the facility audit-ready at all times. Key Responsibilities include: - Scheduling and conducting GCP QA audits to ensure compliance with regulatory requirements - Developing risk-based aud...

Are you ready to lead and optimize strategic partnerships that drive innovation and efficiency in clinical trials At GSK, we are committed to improving lives through groundbreaking research and development. As a Third-Party Management Senior Director, you will play a pivotal role in fostering strong collaborations with external vendors ensuring efficiency, quality, and compliance. The Third-Party Management Director will oversee and optimize the delivery of services and projects through strategic partnerships with external vendors, contractors, and service providers. This role ensures efficient and effective service delivery, upholds high standards of compliance and quality, and manages supp...