$120K - 180K a year
Lead Medical Affairs strategic planning, oversee budgets and vendor relationships, ensure compliance and inspection readiness, and manage operational metrics and cross-functional alignment.
Bachelor’s degree, 10+ years in Medical Affairs operations with 5+ years leadership, project management and budget experience, regulatory compliance expertise, and strong organizational and communication skills.
Description: • Act as strategic thought partner to VP, Medical Affairs, supporting leadership of Medical Affairs Leadership Team (MA-LT) operations and cross-functional alignment. • Lead Medical Affairs strategic and tactical planning cycles (annual functional plan, Integrated Evidence Generation Plan (IEGP), publications, scientific communications plan, etc.). • Drive strategic initiatives to evolve Medical Affairs (e.g., Med Affairs 2.0, upskilling field teams, process optimization). • Integrate insights from internal and external sources into strategic recommendations and portfolio decision-making. • Oversee Medical Affairs budget and resource allocation in partnership with Finance, ensuring alignment with Program Team (PT) and corporate goals. • Develop and manage functional dashboards, Key Performance Indicators (KPIs), and operational metrics to measure impact and enable informed decision-making. • Ensure inspection readiness and adherence to regulatory/compliance standards across Medical Affairs deliverables. • Provide operational leadership for Investigator Sponsored Trials (ISTs), Compassionate Use Program (CUP)/ Expanded Access Program (EAP), Continuing Medical Education (CME) grants, congress operations, and (Key Opinion Leader) KOL engagement. • Manage vendor relationships, contracting operations, Fair Market Value (FMV) processes, and Needs Assessment Form (NAF) navigation. • Oversee functional financial operations (bills, tracking, vendor oversight). • Ensure systems, tools, and shared repositories are well-maintained and consistently utilized. • Coordinate internal Medical Affairs meetings, logistics for congresses, and KOL engagement scheduling. • Support execution, documentation, and reporting for ISTs, CUP, and grants/sponsorships. • Share best practices across Medical Affairs to improve efficiency and standardization. Requirements: • Bachelor’s degree required (preferably in a healthcare-related, scientific, or business discipline); advanced training in project management preferred. • Minimum 10+ years of experience in Medical Affairs operations or related functions within the pharmaceutical/biotech industry, with at least 5 years in a leadership capacity • Proven success in leading Medical Affairs programs and projects and an ability to manage and develop teams, including direct reports and external contractors. • Demonstrated experience in project management, budget oversight, and process optimization in in a dynamic, fast-paced environment. • Expertise in managing operational systems, metrics reporting, and budget oversight. • Experience managing external collaborations and overseeing vendor relationships, contracts, and FMV processes. • Strong understanding of compliance, regulatory, and inspection readiness requirements for Medical Affairs. • Excellent organizational, strategic thinking, and communication skills. • High degree of integrity and commitment to compliance and quality. Benefits: • Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
This job posting was last updated on 10/9/2025