
Posted 14 hours ago
Senior Director, Global Clinical Program Lead
AstraZenecaSenior Director, Global Clinical Program Lead
Requirements
MD, MBBS, PhD, or PharmD, 3+ years clinical research expertise, Knowledge of biostatistics, Knowledge of global regulatory environment, Knowledge of pharmacovigilance
Skills
Clinical ResearchPharmacovigilanceBiostatistics
About the role
Responsibilities
- Lead the design, conduct, monitoring, and medical interpretation of late-phase clinical trials within the Cardiovascular, Renal, and Metabolic (CVRM) therapeutic area.
- Provide strategic medical and scientific expertise to support the initiation, execution, and completion of clinical studies.
- Act as the clinical representative on Global Product Teams and serve as a delegate for the Global Clinical Head.
- Ensure patient safety and ethical compliance in accordance with Good Clinical Practice (GCP) and local regulations.
- Deliver clinical components of essential study documents, including protocols, amendments, and Statistical Analysis Plans.
- Drive medical decision-making within Study Teams and provide scientific clarifications to regulators, ethics committees, and investigators.
- Analyze clinical data to drive interpretations and support the determination of compound benefits and risks.
Requirements
- MD, MBBS, PhD, PharmD, or equivalent scientific doctorate in a relevant discipline.
- 3+ years of clinical research expertise, specifically in study design, protocol development, and trial implementation.
- Strong knowledge of biostatistics, the global regulatory environment, and pharmacovigilance.
- Proven leadership qualities with the ability to collaborate effectively across diverse, global, and multi-cultural settings.
- Excellent oral and written English communication and presentation skills.
Preferred Qualifications
- 3-5 years of experience within the pharmaceutical industry, specifically in R&D.
- Deep medical knowledge in nephrology, cardiology, metabolic diseases, or NASH.
- Formal education in Pharmaceutical Medicine.
- Understanding of the interplay between clinical objectives, drug safety, and commercial requirements.
About the Company
AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. We embrace diversity and equality, working as one collaborative team to help patients all over the world.
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Get started — it's freeSenior Director, Global Clinical Program Lead
AstraZeneca · Boston
