Head, Medical Affairs

Dr Reddy's Laboratories

full-time mid Princeton, NJ, United States · More jobs in Princeton, New Jersey, United States

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Job Description

Job Summary

Dr. Reddy's Laboratories is seeking a visionary Head of Medical Affairs, North America to build and lead the Medical Affairs organization supporting our portfolio of biosimilars, biologics, specialty pharmaceuticals, small-molecule and complex generics for Dr. Reddy’s North America Generics including Dr. Reddy’s Canada. This senior leader will set and deliver the North America medical strategy across the product lifecycle, serve as the organization's senior scientific advisor, and partner closely with Commercial, Portfolio, R&D;, Regulatory Affairs, Market Access, Business Development, Pharmacovigilance, and Global Medical Affairs.

Roles & Responsibilities

• Define and execute the North America Medical Affairs strategy across biosimilars, biologics, specialty products, generics and complex generics.
• Serve as the senior medical authority for all North America products and pipeline assets.
• Lead medical launch readiness, evidence generation, publication planning, and scientific communications.
• Provide scientific input on portfolio selection, development programs, and regulatory interactions, including therapeutic equivalence, biosimilarity, and interchangeability.
• Oversee real-world evidence, HEOR, investigator-sponsored studies, and post-marketing research.
• Build KOL engagement strategy, lead advisory boards, and represent Dr. Reddy's at major scientific conferences.
• Run advisory boards, scientific exchange programs and expert consultations to shape development and commercial strategy.
• Scope, build and lead a high-performing team including MSLs, HEOR, Scientific Communications, and Medical Information.
• Partner with Commercial and Market Access on payer value propositions and participate in promotional and Legal-Medical-Regulatory reviews.
• Lead medical due diligence for licensing, acquisition, and portfolio expansion opportunities.
• Assess clinical differentiation, unmet needs, competitive landscapes and evidence needs for potential new assets.
• Ensure compliance with FDA regulations, PhRMA Code, OIG guidance, and internal SOPs and governance standards.
• Work closely with Pharmacovigilance and Quality on medical review of safety and product-related matters.
• Set up and maintain Medical Affairs SOPs, governance processes and quality standards.