Senior Manager, Clinical Sciences

Apotex; Mumbai, Bengaluru; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Apotex in Mumbai seeks a Senior Manager, Clinical Sciences to lead strategic planning, execution, and oversight of clinical development programs with a focus on 505(b)(2) regulatory pathways and PK studies.

The role collaborates with Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Pharmacovigilance, Data Management, and external CROs to ensure timely development activities compliant with GCP standards.

Qualifications

• MD (Pharmacology), MBBS or PharmD required.
• Ten-plus years in 505(b)(2) development programs and patient-based PK studies.
• Experience in clinical strategy and regulatory interactions.

Responsibilities

• Develop and execute clinical development strategies for 505(b)(2) products.
• Lead protocol development for Phase I–IV studies, including patient-based PK studies.
• Provide scientific input into product development plans and clinical positioning.
• Support target product profile development and regulatory strategy.
• Lead/pre-IND interactions with the US FDA and related meeting preparations.
• Oversee biosimilar development for USFDA submissions.

Education

MD (Pharmacology)

MBBS

PharmD

Job description

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