Manager, Clinical Development – Clinical Sciences

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.