Sr. Manager – Clinical Development
Location: Mumbai / Gurgaon, India
Business Unit: Global Drug Development (GDO)
Job Grade: G9A/B
Employment Type: Full-Time
Company: Sun Pharmaceutical Industries Ltd.
Job Summary
The Sr. Manager – Clinical Development (Clinical Development Study Lead) is responsible for providing medical and scientific leadership for clinical development programs and clinical studies across multiple phases of drug development.
The incumbent will lead cross-functional study teams, oversee study design and execution, provide medical monitoring, support regulatory interactions, and ensure timely delivery of clinical development objectives aligned with the overall asset strategy. The role serves as the primary medical accountable person for assigned clinical studies and plays a critical role in driving high-quality clinical research that delivers value to patients and the organization.
Key Responsibilities
Clinical Development Leadership
Lead and manage cross-functional Clinical Study Teams.
Serve as the primary medical lead and point of accountability for assigned clinical studies.
Drive study strategy, planning, execution, and delivery in alignment with asset development goals.
Ensure study objectives support regulatory, scientific, and commercial requirements.
Foster collaboration, innovation, and efficient decision-making within study teams.
Clinical Trial Design & Execution
Lead clinical studies from concept through study completion.
Develop robust clinical study designs that support regulatory approval and market differentiation.
Oversee:
Protocol development
Clinical study planning
Medical monitoring
Data review and interpretation
Clinical study reporting
Regulatory submission support
Ensure clinical studies are conducted according to approved protocols and timelines.
Medical Monitoring & Data Review
Perform or oversee medical monitoring activities for ongoing clinical studies.
Conduct clinical data review and medical assessment of emerging safety and efficacy information.
Interpret clinical study results and provide scientific recommendations.
Identify trends, risks, and potential issues affecting study outcomes.
Ensure data integrity and scientific validity throughout the study lifecycle.
Cross-Functional Team Leadership
Lead collaboration across multiple functional areas, including:
Clinical Operations
Regulatory Affairs
Biostatistics
Data Management
Pharmacovigilance
Quality Assurance
Clinical Pharmacology
CMC (Chemistry, Manufacturing & Controls)
Medical Affairs
Commercial Teams
Drive alignment across stakeholders to achieve study milestones and deliverables.
Facilitate efficient communication and decision-making processes.
Vendor & CRO Management
Collaborate with Contract Research Organizations (CROs) and external vendors.
Participate in vendor selection, study planning, and oversight activities.
Monitor vendor performance and study execution quality.
Ensure external partners meet study timelines and quality expectations.
Regulatory & Compliance Support
Support interactions with global regulatory authorities.
Assist in preparation of:
Regulatory submissions
Briefing documents
Clinical summaries
Scientific presentations
Participate in meetings with regulatory agencies and Data Monitoring Committees.
Ensure compliance with:
Good Clinical Practice (GCP)
ICH Guidelines
FDA Regulations
EMA Regulations
Global Clinical Development Standards
Risk Management & Governance
Identify study-related risks and develop mitigation strategies.
Monitor study progress and proactively address operational or scientific challenges.
Present study updates and recommendations to project governance committees.
Ensure timely escalation of critical risks and issues.
External Scientific Engagement
Represent the Study Team at:
Investigator Meetings
Scientific Advisory Boards
Clinical Research Forums
Key Opinion Leader (KOL) Interactions
Collaborate with Medical Affairs and Commercial teams on scientific engagement initiatives.
Support scientific communication and external stakeholder relationships.
Continuous Improvement & Team Development
Promote a culture of excellence, accountability, and continuous improvement.
Mentor and support team members in professional development.
Encourage knowledge sharing and adoption of best clinical development practices.
Contribute to organizational learning and innovation initiatives.
Educational Qualifications
Required
MD
MD + DM
MD/PhD
Preferred
Specialization in relevant therapeutic areas.
Advanced clinical research and drug development expertise.
Experience Requirements
Required
Minimum 4+ years of pharmaceutical, biotechnology, or clinical development experience.
Experience leading or supporting clinical development programs.
Experience working in cross-functional matrix organizations.
Preferred
Experience across multiple phases of drug development (Phase I–IV).
Hands-on experience managing global clinical trials.
Experience in medical monitoring and clinical data review.
Exposure to regulatory interactions and submission activities.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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