Head, Medical Affairs

Dr Reddy's Laboratories Limited; Princeton (NJ); On-site; USD 250,000 - 350,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Medical Affairs leadership

Biosimilars knowledge

Strategic thinking

Stakeholder management

Regulatory knowledge (FDA)

Publication planning

KOL engagement

HEOR & real-world evidence

Team building

Scientific communication

Education

MD/DO/PharmD/PhD

Job description

• Job Family: Medical Affairs & Pharmacovigilance
• Sub Job Family: Medical Affairs & Information
• Preferred type of working: On-Premise
• Years of Experience: 12 - 20
• Business unit: Biologics

Company Description

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Diversity, Equity & Inclusion
At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

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.

• 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.

Qualifications

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.

Skills & attributes:

• Experience across biosimilars, biologics, small-molecule/complex generics strongly preferred.
• Proven success leading Medical Affairs for product launches and building field medical teams. Ideal candidate to have prior Medical Affairs experience at both large and smaller pharma organizations.
• Therapeutic expertise in Oncology, Immunology/Rheumatology, Rare Disease, or Neurology.
• 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.

Additional Information

Our Work Culture
Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.