Senior Manager

Apotex Inc.; Bengaluru; Sur place; INR 2 500 000 - 4 000 000; Plein temps

Résumé du poste

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

You will collaborate across Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, and Pharmacovigilance to ensure timely delivery. The role requires MD/MBBS/PharmD with strong experience in PK, regulatory interactions, and cross-functional

Qualifications

• MD (Pharmacology), MBBS or PharmD with clinical development experience.
• Experience leading 505(b)(2) development programs and regulatory interactions.
• Strong background in PK/clinical pharmacology and cross-functional collaboration.

Responsabilités

• Develop and execute clinical development strategies for 505(b)(2) products and lifecycle management.
• Lead protocol development for Phase I-IV studies, including patient-based PK studies.
• Provide scientific input into product development plans and regulatory strategies.
• Evaluate development pathways for new assets and reformulations and support TPP development.
• Lead or support pre-IND interactions with the US FDA and related meeting preparations.

Connaissances

Clinical development strategy

505(b)(2) pathway

Pre-IND interactions

Pharmacokinetics (PK)

Regulatory collaboration

Formation

MD (Pharmacology)

MBBS

PharmD

Description du poste

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 strong 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.

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
• Dose proportionality 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