Head, Medical Affairs

Job Summary

Dr. Reddys 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. Reddys North America Generics including Dr. Reddys Canada. This senior leader will set and deliver the North America medical strategy across the product lifecycle serve as the organizations 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. Reddys 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 510 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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.

For more details please visit our career website at Work :

No

Employment Type :

Full-time