Senior Manager- Clinical Sciences

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

Job summary

AMS is seeking an experienced clinical development leader to drive 505(b)(2) development programs and lifecycle management. You will oversee protocol design for Phase I–IV studies, coordinate Pre-IND interactions with the US FDA, and contribute to regulatory strategy and product development plans with a strong PK focus.

The role emphasizes collaboration with Regulatory Affairs, Clinical Pharmacology, and Biostatistics to ensure robust study designs and evidence packages for US FDA submissions.

Qualifications

• MD in Pharmacology, MBBS or PharmD required.
• 10–12 years in 505(b)(2) development and patient-based PK studies.
• Experience with Pre-IND (PIND) interactions and FDA meetings.

Responsibilities

• 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 and medical input into product development plans.
• Evaluate clinical feasibility and development pathways for new assets and reformulations.
• Support TPP development and clinical positioning strategy.
• Lead or support US FDA Pre-IND interactions (PIND).
• Lead PK/clinical development contributions to Pre-IND meeting preparations.
• Biosimilar development for USFDA submission.
• Design and execute 505(b)(2) development programs.
• Assess literature, RLDs, bridging requirements and evidence needs.
• Collaborate with Regulatory Affairs on FDA interactions and meetings.
• Support integrated clinical and regulatory strategies.
• Plan and execute patient-based PK, relative bioavailability, food effect, and DDI studies.
• Review PK reports and interpret data.
• Work with Clinical Pharmacology, Biostatistics, and Regulatory teams.

Skills

Clinical strategy

Regulatory interactions

PK planning

Literature assessment

Biosimilar development

Education

MD Pharmacology

MBBS

PharmD

Job description

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

Experience Requirements

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