Head, Medical Affairs

Dr Reddy's Laboratories Limited•Princeton, NJ

15h

About The Position

Dr. Reddy’s Laboratories is seeking a visionary Head of Medical Affairs, North America, to build and lead the Medical Affairs organization supporting its portfolio of biosimilars, biologics, specialty pharmaceuticals, small-molecule and complex generics for Dr. Reddy’s North America Generics, including Dr. Reddy’s Canada. The role sets and delivers the North America medical strategy across the product lifecycle, serves as the organization’s senior scientific advisor, and partners with Commercial, Portfolio, R&D, Regulatory Affairs, Market Access, Business Development, Pharmacovigilance, and Global Medical Affairs. The position leads medical launch readiness, evidence generation, publication planning, scientific communications, real-world evidence, HEOR, investigator-sponsored studies, and post-marketing research. It develops KOL engagement and scientific exchange programs, represents Dr. Reddy’s at scientific conferences, and provides scientific input on portfolio selection, development programs, and regulatory interactions. The Head scopes, builds, and leads a high-performing team spanning MSLs, HEOR, Scientific Communications, and Medical Information; partners with Commercial and Market Access on payer value propositions; and participates in promotional and Legal-Medical-Regulatory reviews. The role also leads medical due diligence for licensing, acquisition, and portfolio expansion opportunities; assesses clinical differentiation, unmet needs, competitive landscapes, and evidence needs; and ensures compliance with FDA regulations, the PhRMA Code, OIG guidance, internal SOPs, and governance standards. It works with Pharmacovigilance and Quality on medical review of safety and product-related matters and establishes and maintains Medical Affairs SOPs, governance processes, and quality standards.

Requirements

MD, DO, PharmD, or PhD required.
15+ years of progressive pharmaceutical or biopharmaceutical experience.
5–10 years in Medical Affairs leadership.
Strong knowledge of FDA regulatory pathways, promotional compliance, HEOR, and real-world evidence.
Executive presence with excellent communication, strategic thinking, and stakeholder management skills.
Strong commitment to compliance, ethics, and patient-centered decision making.

Nice To Haves

Board certification or post-doctoral clinical training.
Experience across biosimilars, biologics, small-molecule or complex generics.
Proven success leading Medical Affairs for product launches and building field medical teams.
Prior Medical Affairs experience at both large and smaller pharmaceutical organizations.
Therapeutic expertise in Oncology, Immunology/Rheumatology, Rare Disease, or Neurology.

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 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 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, the PhRMA Code, OIG guidance, and internal SOPs and governance standards.
Work 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.