North America Medical Affairs Lead – Biosimilars

Dr Reddy's Laboratories Limited; Princeton (NJ); Presencial; USD 250.000 - 350.000; Jornada completa

Descripción de la vacante

Dr. Reddy's Laboratories Limited seeks a visionary Head of Medical Affairs, North America to build and lead the Medical Affairs organization for biosimilars, biologics, and specialty products across NA.

This senior leader will set the medical strategy, serve as the scientific advisor, and collaborate with Commercial, R&D, Regulatory, Market Access and Pharmacovigilance. You will define the medical strategy, lead launch readiness, evidence generation, and advisory boards, while ensuring

Formación

• Educational qualification: MD, DO, PharmD or PhD required; board certification or post-doctoral clinical training preferred.
• Minimum work experience: 15+ years of progressive pharmaceutical/biopharmaceutical experience, including 5–10 years in Medical Affairs leadership.

Responsabilidades

• Define and execute the NA 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.

Conocimientos

Medical Affairs leadership

Biosimilars knowledge

Strategic thinking

Stakeholder management

Regulatory knowledge (FDA)

Publication planning

KOL engagement

HEOR & real-world evidence

Team building

Scientific communication

Educación

MD/DO/PharmD/PhD

Descripción del empleo

Dr. Reddy's Laboratories Limited seeks a visionary Head of Medical Affairs, North America to build and lead the Medical Affairs organization for biosimilars, biologics, and specialty products across NA.

This senior leader will set the medical strategy, serve as the scientific advisor, and collaborate with Commercial, R&D, Regulatory, Market Access and Pharmacovigilance. You will define the medical strategy, lead launch readiness, evidence generation, and advisory boards, while ensuring