Associate Director, Medical Affairs Research; Investigator Studies

Job Description General / Position Summary

The Investigator Sponsored Studies (ISS) Associate Director is responsible for overseeing the systems, processes, and daily operations of the ISS operations program in Medical Affairs. This position will provide direction and oversight of the ISS process to ensure all requests are reviewed in compliance with all external regulations, industry guidelines, and Vertex policies.

• Lead the ISS and research collaboration programs, including overall strategy, process enhancements, and day-to-day management, while ensuring compliance with Vertex policies across disease areas
• Manages the strategy and areas of interest development for each disease area during the annual medical planning process
• Stay informed on industry best practices and benchmarking data and incorporate into process enhancements
• Participates in the ISS Committee meetings, ensuring consistency across disease areas in decision-making
• Actively participates in DTE roadmap discussions for process improvements to the request management system
• Engages in frequent external applicant interactions and communicates with internal stakeholders that are involved in these application/review processes
• Proactively communicates ISS status reports and impact metrics to internal stakeholders
• Works with Finance and medical stakeholders to develop annual budgets for ISS and research collaborations, track budgets, and attend forecast meetings
• Work with contracting, and Legal, if necessary, to manage overall contracting process
• Establishes, maintains, and leads training on request management systems that effectively support the review/approval process, archiving and maintenance of all ISS programs
• Leads of the Vertex Research Award Programs (Research Innovation Award [RIA], Vertex Innovation Awards [VIA], and, if necessary, Circle of Care), and identifies process improvements for the programs. Also collects benchmarking data and communicates with internal stakeholders to determine if and when to open an award program in a new disease area
• Frequently communicates with all internal contacts (e.g. Global Medical Affairs, Legal/IP, Compliance, Biostatistics, Patient Safety, Clinical Development, Research, etc.)
• Manages team of direct reports and may have financial accountabilities and human resource responsibilities for assigned staff
• Actively contributes to Grants and Giving Team Meetings and works with Grants and Giving Lead to continually enhance team culture
• Leads the creation and expansion of metric reports for Grants, Sponsor ships, and ISS to ensure consistency in reporting
• Report to Grants and Giving Lead with dotted line to other AD, External Funding Research

• Bachelor’s degree required
• Previous ISS and/or research management experience strongly preferred
• Typically requires 8 years of experience with relevant experience in the pharmaceutical/biotech industry
• Supervisory/management experience preferred

• Strong communication skills (verbal and written) to exchange complex information with others
• Strong ability to identify and solve complex, technical and operational problems
• Strong project management skills
• Ability to complete goals within allotted time frames and deliver high-quality results
• Strong initiative and ability to identify issues and create solutions
• inadept with Microsoft programs (Word, PowerPoint, Excel, Teams, PowerBI) as well as online meeting platforms (Zoom and Teams)
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• Expert knowledge of relevant guidelines that impact the conduct of such programs, including, but not limited to: medical and regulatory affairs, drug development, FDA and regulatory…