Position Summary  

The Director, Medical Affairs Research Operations reports to the Senior Director, Managed Access and Data Generation Operations within Global Medical Affairs. The role provides strategic and operational leadership for the governance, review, and delivery of Medical Affairs research, with accountability for execution of the global externally sponsored research portfolio. 

Working closely with Global and Affiliate Medical Affairs, Health Economics and Outcomes Research, Clinical Development, and other cross-functional partners, the Director supports the development, implementation, tracking, and reporting of evidence generation plans. 

The Director drives portfolio governance, operational excellence, compliance, and continuous improvement across Medical Affairs Research Operations. The role also leads the evaluation and implementation of AI-enabled technologies, automation, and advanced analytics to improve operational efficiency, portfolio visibility, decision-making, and the stakeholder experience. 

Principal Responsibilities 

Medical Affairs Research Governance 

• Lead and oversee Medical Affairs research governance processes globally 

• Coordinate and administer research governance review committees, including the Therapeutic Area Review Committees governance activities. 

• Perform operational and scientific review of research proposals as a core governance committee member. 

• Ensure compliance with applicable regulatory, legal, ethical, and company requirements relating to evidence generation activities 

Execution and Leadership  

• Accountable for the execution of the global externally sponsored research portfolio, including allocation of team resourcing  

• Provide strategic direction and leadership for Data Generation Operations personnel supporting the portfolio 

• Collaborate with Therapeutic Area Medical Affairs teams to develop and implement evidence generation plans. 

• Support evidence dissemination activities and maximize the value of Medical Affairs-generated evidence 

• Serve as the primary Medical Affairs operational partner for forecasting, budgeting, and resource planning associated with evidence generation activities. 

• Oversee vendor management and external partner relationships supporting evidence generation operations 

Evidence Generation Tracking and Reporting  

• Own and continuously enhance the infrastructure, processes, and tools used to track and report Medical Affairs evidence generation activities globally. 

• Provide portfolio-level reporting, performance metrics, and strategic insights to Medical Affairs leadership 

• Ensure data quality, transparency, and visibility across all evidence generation activities. 

• Use data-driven approaches to identify risks, opportunities, resource needs, and portfolio trends. 

AI, Digital Innovation and Automation  

• Identify opportunities to leverage artificial intelligence, automation, and advanced analytics to optimize Medical Affairs research governance and evidence generation operations. 

• Lead the assessment, implementation, and adoption of AI-enabled solutions that improve portfolio management, workflow efficiency, reporting, compliance monitoring, and stakeholder experience.  

• Drive a culture of continuous improvement and digital innovation across Medical Affairs Research Operations. 

Qualifications 

• Minimum 7 years of research management or evidence generation experience in the pharmaceutical, biotechnology, healthcare, or life sciences sector 

• Demonstrated leadership of cross-functional teams and global programs 

• Experience in Medical Affairs, clinical research, real-world evidence, or related research governance environments. 

• Experience leading process improvement, digital transformation, or operational excellence initiatives. 

• Experience evaluating and implementing AI-enabled solutions, automation technologies, advanced analytics platforms, or digital workflow tools. 

• Excellent verbal and written communication skills in English are required.   

• Proficiency with office and enterprise software tools 

Education 

• MD, PhD, or Pharm D preferred.