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Director, Medical Affairs

0-2 years
Not Disclosed
10 Sept. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: [Role Name]

Location: Hyderabad, India
Division: US
Business Unit: Universal Hierarchy Node
Company / Legal Entity: IN10 (Novartis Healthcare Private Limited)
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
Reporting To: Head of Evidence Generation, US


About the Role

This leadership role is responsible for overseeing USMA clinical studies (IITs, RCs, NIS) and managing RWE analytics, economic modeling, biostatistics, and data management teams from the Hyderabad site. The position requires a strong functional leader who can drive operational excellence, ensure compliance, foster collaboration, and influence senior leaders globally.


Key Responsibilities

Operational Leadership

  • Lead and oversee execution of USMA clinical studies (IITs, RCs, NIS).

  • Manage RWE analytics, economic modeling, biostatistics, and data management functions.

  • Establish robust local processes, team structures, and performance management systems.

  • Ensure timely, high-quality, and compliant delivery of evidence generation (EG) outputs.

  • Develop and meet operational KPIs contributing to overall USMA success.

  • Proactively identify delivery risks and implement mitigation strategies.

Team & People Management

  • Oversee a team of 10–45 direct reports with potential for expansion.

  • Drive hiring, onboarding, training, and long-term capability building.

  • Provide performance feedback in alignment with Novartis leadership.

  • Manage corrective actions or termination as per company policy and regulations.

  • Build a culture of collaboration, innovation, and continuous improvement.

Stakeholder Engagement & Communication

  • Maintain clear communication with USMA leadership and US-based functional heads.

  • Represent Hyderabad EG operations in senior forums and contribute to strategic planning.

  • Develop and present executive-level reports and dashboards to local and US leadership.

  • Foster cross-site alignment across NOCC locations and harmonize ways of working.


Minimum Requirements

  • Experience: 8–10 years in multinational pharmaceutical or CRO environments.

  • Proven expertise in leading end-to-end clinical study operations (IITs, RCs, NIS).

  • Strong track record in RWE analytics, data science, economic modeling, and biostatistics.

  • In-depth knowledge of regulatory, quality, and compliance standards in EG.

  • Strong business acumen with budget oversight, resource planning, and P&L management.

  • Experience managing complex programs in dynamic environments.

  • Skilled in remote team management (onshore/offshore).

  • Ability to lead cross-functional teams in matrixed, multicultural settings.


Education

  • Advanced degree in Life Sciences, Pharmacy, Health Economics, Statistics, Public Health, or related field (e.g., PhD, MPH, MSc, PharmD).


Preferred Requirements

  • Executive presence and ability to influence senior stakeholders.

  • Excellent communication and analytical skills; fluent in English (written & spoken).

  • Experience with US work culture, healthcare landscape, and terminology.

  • High emotional intelligence with strong team-building capabilities.

  • Financial acumen, including budget and resource planning.

  • Familiarity with EG systems, governance, and data platforms.

  • Willingness to travel internationally (up to 30%).

  • Flexibility to work US business hours (up to 8:00 p.m. IST).


Why Novartis

At Novartis, our purpose is to reimagine medicine to improve and extend people’s lives. Our vision is to be the most valued and trusted medicines company in the world. We believe our people are the driving force behind this mission.


Commitment to Diversity & Inclusion

Novartis is committed to creating an inclusive work environment with diverse teams representative of the patients and communities we serve. If you require reasonable accommodation during the recruitment process or to perform essential job functions, please contact: diversityandincl.india@novartis.com (include the job requisition number).


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