Senior Manager, Clinical Sciences

Job Title- Senior Manager - Clinical Sciences

Department- Clinical Development and Toxicology

Reporting To- General Manager - Clinical Development and Toxicology

Position Summary

The Senior Manager, Clinical Sciences, will be responsible for the strategic planning, execution, and oversight of clinical development programs, with a strong focus on 505(b)(2) regulatory pathways, patient-based pharmacokinetic (PK) studies, bioavailability/bioequivalence strategies, 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:

1. Patient-based PK studies

2. Relative bioavailability studies

3. Food effect studies

4. Dose proportionality studies

5. Drug-drug interaction studies

6. 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) OR MBBS OR PharmD

Experience Requirements

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