Senior Manager, Medical Research

Job Description

Job Summary:

• The Senior Manager, Medical Research – IIS & Research Collaborations plays a key role in advancing externally sponsored research initiatives.
• In this position, you will lead the operational execution and oversight of Investigator Initiated Studies (IIS) and Research Collaborations (RC), working closely with cross-functional teams to ensure efficient study execution.
• You will serve as a central point of contact for investigators, internal teams, and vendors, ensuring high-quality execution and oversight of the externally sponsored research.
• This role is ideal for a detail-oriented, relationship-driven scientific operations professional who thrives in a fast-moving, global environment.

Duties and Responsibilities:

• Serve as the primary point of contact for IIS and RC activities across regions.
• Manage communications and relationships with investigators, academic partners, and internal stakeholders.
• Oversee the full lifecycle of externally sponsored research, including concept intake, review, budget approval, contracting, study execution, and close‐out.
• Coordinate Medical Affairs Review Board (MARB) meetings, including agenda development, document preparation, and minutes management.
• Track IIS/RC metrics and provide regular updates to Medical Affairs leadership.
• Ensure inspection readiness through complete, accurate, and readily retrievable documentation.
• Partner with GPSRM and QA to support audits and inspections.
• Provide oversight and collaborate with IIS portal vendor on issues and updates.
• Accountable for ensuring drug shipment activities comply with local/regional requirements and Client quality standards.
• Management of IIS and RC budgets, including annual budget planning.
• Proactively identify operational challenges and propose practical solutions.
• Contribute to initiatives aimed at improving investigator experience and internal efficiencies.
• Uphold and model Client Core Values in every aspect of work.

Education and Experience:

• BA/BS in Life Sciences or related field is required.
• Advanced degree or certification preferred.
• Proven experience in the pharmaceutical/biotech industry, prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies.
• Experience managing externally sponsored research (IIS/RC) strongly preferred.

Knowledge, Skills and Abilities:

• Strong working knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
• Excellent verbal and written communication skills.
• Strong relationship-building and stakeholder management capabilities.
• Highly organized, detail-oriented, and able to work independently.
• Solution-oriented mindset with strong problem-solving skills.
• Committed to high quality, integrity and alignment with Core Values.