Job Title- Senior Manager - Clinical SciencesPosition SummaryThe Senior Manager, Sr. Manager Clinical Sciences, will be responsible for the strategic planning, execution, and oversight of clinical development programs, with a solid 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 ResponsibilitiesClinical Development StrategyDevelop 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 submission505(b)(2) Development ProgramsDesign 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 StudiesLead planning and execution of: Patient-based PK studiesRelative bioavailability studiesFood effect studiesDose proportionality studiesDrug-drug interaction studiesSpecial population studiesReview PK study reports and interpret pharmacokinetic data.Collaborate with Clinical Pharmacology, Biostatistics, and Regulatory teams for study design and data interpretation.QualificationsEducational RequirementsMD (Pharmacology)MBBSPharmDInterested candidates can share your CV to [email protected]

📌 Senior Manager (Bengaluru)
🏢 Apotex
📍 Bengaluru