Job Title- Senior Manager - Clinical Sciences

Position Summary

The Senior Manager, Sr. Manager Clinical Sciences, will be responsible for the strategic planning, execution, and oversight of clinical development programs, with a robust focus on 505(b)(2) regulatory pathways, patient-based pharmacokinetic (PK) studies, and early to late-stage clinical development activities.

The individual will work closely with Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Pharmacovigilance, Data Management, and external investigators/CROs to ensure successful and timely execution of development programs while maintaining compliance with applicable regulatory requirements and GCP standards.

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 new 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

Interested candidates can share your CV to [email protected]

📌 Senior Manager (Bengaluru)
🏢 Apotex
📍 Bengaluru