Associate Director – Medical Affairs
Job ID: REQ-10064365
Location: Hyderabad, India (#LI Hybrid)
Division: Development
Business Unit: Universal Hierarchy Node
Employment Type: Full-time, Regular
Shift: No
Summary
The Associate Director – Medical Affairs (AD-MA) is a key member of the Global Medical Affairs (GMA) team, serving as the enterprise medical voice across the asset lifecycle and leading medical strategy for the therapeutic area (TA).
The role is responsible for:
Developing and owning Integrated Evidence Packages (IEP) and contributing to global medical strategy.
Implementing medical strategies for early-stage programs worldwide, including interventional studies, non-interventional studies (NIS), real-world evidence (RWE) studies, and implementation science projects.
Managing complex assets and situations with high scientific complexity or regulatory challenges, requiring pharmacovigilance expertise.
Acting as a subject matter expert and providing leadership, medical expertise, and representation of GMA to senior stakeholders.
Acting as a strategic partner to NIBR, Development, International Medical Affairs, and US Medical Affairs.
Overseeing Managed Access Programs (MAPs) and Post Study Drug Supply (PSDS).
Supporting lifecycle management of in-market brands and medical information activities.
Key Responsibilities
Medical Strategy & Leadership
Lead development and execution of medical affairs strategy for TA/asset priority programs.
Implement transformative tactics, including research/population health, innovative partnerships, and integrated evidence plans.
Provide leadership and deep medical expertise in the therapeutic area, adjusting support based on business priorities.
Represent GMA at GPTs and with internal/external stakeholders.
Evidence Generation & Program Execution
Co-develop plans for evidence generation, MSL/Field Medical Affairs strategy, medical education programs, scientific publication planning, and Medical Expert network development.
Partner with Development, S&G, US, and International cross-functional teams to shape portfolio early and diversify evidence for broad access at launch.
Provide proactive input on potential new therapeutic indications and enrich registration programs.
Managed Access & Post Study Drug Supply
Create MAP treatment strategies and secure leadership endorsement in coordination with line functions and program safety.
Develop PSDS cover letters highlighting compound-specific information for physicians, including risk minimization materials.
Support patient consent/assent, product form, baseline/follow-up questions, and statistical analysis/publication plans (MSAPP) as applicable.
Stakeholder Engagement
Serve as a strategic partner to TA teams and life-cycle management of in-market brands.
Collaborate with internal and external stakeholders, including the investment, medical, regulatory communities, and pharmaceutical/biotech partners.
Establish credibility and influence in a matrix organization to drive cross-functional collaboration and change.
Essential Requirements
Education: MD preferred; PhD/PharmD in Health Sciences acceptable. Specialist qualifications related to the discipline are an advantage.
Experience: At least 10 years in Medical Affairs and/or Clinical Development within the pharmaceutical industry.
Skills:
Critical thinking and ability to navigate uncertainty with minimal supervision.
Fluency in English; other languages advantageous.
Strong collaboration and co-creation skills across functions and markets.
Knowledge of GCP, scientific and clinical methodology, protocol design, management, and regulatory requirements.
Desirable Requirements
Therapeutic area expertise.
Significant experience in early asset lifecycle, pre-launch, and launch phases.
Experience developing and executing “Best in Class” processes at scale.
Clinical trial research experience in pharmaceutical or academic settings within the TA of interest.
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities served.
Accessibility & Accommodation
Reasonable accommodations are available for individuals with disabilities during recruitment or to perform essential job functions. Contact: diversityandincl.india@novartis.com with the job requisition number and details of your request.
Why Novartis?
Novartis aims to reimagine medicine to improve and extend people’s lives. Our associates drive innovation and collaboration to achieve breakthroughs that change patients’ lives.
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