Key Responsibilities

Clinical Development Strategy

- Develop and execute clinical development strategies for 505(b)(2) products and lifecycle management programs.
- Lead protocol development for Phase I-IV clinical studies, including patient-based PK studies.
- Provide scientific and medical input into product development plans.
- Evaluate clinical feasibility and development pathways for current assets and reformulations.
- Support target product profile (TPP) development and clinical positioning strategy.
- Hands-on experience leading or supporting Pre-IND (PIND) interactions with the US FDA.
- Lead clinical development contributions to US FDA Pre-IND (PIND) meeting preparations.
- Biosimilar drug development for USFDA submission

505(b)(2) Development Programs
- Design and execute development programs utilizing the 505(b)(2) regulatory pathway.
- Assess literature, reference listed drugs (RLDs), bridging requirements, and clinical evidence needs.




- Collaborate with Regulatory Affairs on FDA interactions, briefing books, pre-IND, Type B, and other regulatory meetings.
- Support development of integrated clinical and regulatory strategies.

PK and Clinical Pharmacology Studies
- Lead planning and execution of:

Patient-based PK studies

Relative bioavailability studies

Food effect studies

Dose proportionality studies

Drug-drug interaction studies

Special population studies

- Review PK study reports and interpret pharmacokinetic data.
- Collaborate with Clinical Pharmacology, Biostatistics, and Regulatory teams for study design and data interpretation.

Qualifications

Educational Requirements

- MD (Pharmacology)
- MBBS
- PharmD

Experience Requirements 10-12 years of experience in 505(b)(2) development programs, Patient-based PK studies and clinical strategy

📌 Senior Manager- Clinical Sciences (Bengaluru)
🏢 AMS
📍 Bengaluru