[Hiring] Associate Director, Medical Affairs Research @Vertex Inc.

Role Description

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.
• Manage 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.
• Participate in the ISS Committee meetings, ensuring consistency across disease areas in decision-making.
• Actively participate in DTE roadmap discussions for process improvements to the request management system.
• Engage in frequent external applicant interactions and communicate with internal stakeholders involved in these application/review processes.
• Proactively communicate ISS status reports and impact metrics to internal stakeholders.
• Work 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 the overall contracting process.
• Establish, maintain, and lead training on request management systems that effectively support the review/approval process, archiving, and maintenance of all ISS programs.
• Lead the Vertex Research Award Programs (Research Innovation Award [RIA], Vertex Innovation Awards [VIA], and, if necessary, Circle of Care), and identify process improvements for the programs.
• Collect benchmarking data and communicate with internal stakeholders to determine if and when to open an award program in a new disease area.
• Frequently communicate with all internal contacts (e.g., Global Medical Affairs, Legal/IP, Compliance, Biostatistics, Patient Safety, Clinical Development, Research, etc.).
• Manage a team of direct reports and may have financial accountabilities and human resource responsibilities for assigned staff.
• Actively contribute to Grants and Giving Team Meetings and work with Grants and Giving Lead to continually enhance team culture.
• Lead the creation and expansion of metric reports for Grants, Sponsorships, and ISS to ensure consistency in reporting.
• Report to Grants and Giving Lead with a dotted line to other AD, External Funding Research.

Qualifications

• 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.

Requirements

• 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 timeframes and deliver high-quality results.
• Strong initiative and ability to identify issues and create solutions.
• Proficient 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 guidelines (i.e., PhRMA guidelines, ICH-GCP, IRB, Sunshine Act, etc.) and compliance around ISS Programs.
• Advanced knowledge of ISS request management systems.

Benefits

• Annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• Inclusive market-leading benefits to meet employees' career, financial, family, and wellbeing journey.
• Medical, dental, and vision benefits.
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter).
• Educational assistance programs including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) and more.

Company Description

Vertex is a global biotechnology company that invests in scientific innovation.