Senior Manager

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. - 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 rprathap@apotex.com