Overview
Manager, Clinical Development – Clinical Sciences supports clinical programs for product evaluation, development, and testing across multiple therapeutic areas.
What you'll do
- Independently lead, author, or review clinical development plans, including clinical protocols and study documents (pre-IND, IND, NDA) for assigned clinical sections.
- Perform literature searches and help strategize clinical study design aspects such as sample size, endpoints, and duration for Phase 1–3 trials.
- Provide clinical inputs for conceptualization, validation, feasibility, and collaborate with cross-functional teams.
- Implement study-related operational plans and oversee analysis of Phase 1–2 study data, communicating results.
- Oversee and review project work at external partnered sites and guide when needed.
- Manage study oversight activities including initiation, monitoring, closeout, and routine follow-up/communication with external partners (CROs).
What you'll need
- Minimum 6+ years of drug development experience.
- Extensive experience in Phase 1 clinical pharmacology studies and moderate experience in late-phase trials.
- Knowledge of ICH guidelines and GCP, plus understanding of regulatory guidelines and clinical requirements.
- Experience with analysis of research data and publications.
- Working knowledge of biostatistics and pharmacokinetics.
- Strong organizational, interpersonal, and verbal/written communication skills; ability to work cross-functionally.
Nice to have
- 505(b)(2) drug development experience.
- Worked with WinNonlin or other PK software.
- M.Pharm/Pharm.D/Ph.D in clinical pharmacy or pharmacology.
Details
- Location: Hyderabad, India.
- Reports to the Director, Clinical Development.
Read the full description and apply on the company’s own careers page.
