Introduction Our client is a clinical-stage biotechnology company focused on developing locally delivered, extended-release pharmaceutical products to address areas of high unmet medical need. Utilizing proprietary polymer-based microsphere technology, the company aims to enhance the safety, efficacy, and duration of drug therapies through targeted delivery. They are currently advancing treatments in osteoarthritis, eosinophilic esophagitis (EoE), and other gastrointestinal diseases, with a growing pipeline that extends into additional therapeutic areas. They are seeking a Director of Medical Affairs to lead Key Opinion Leader (KOL) engagement strategies, medical education initiatives, and conference activities. This individual will play a critical role in shaping the companys market presence, building advocacy, and supporting pre- and post-approval commercialization efforts. Responsibilities Develop and execute KOL engagement strategies to support market preparation and product positioning across osteoarthritis, EoE, and gastrointestinal indications. Identify, engage, and cultivate relationships with KOLs in the US, EU, and other key markets. Lead medical education initiatives and manage scientific engagement at congresses, advisory boards, and regional/national meetings. Communicate the evidence base supporting the companys products to KOLs, advocacy groups, and other stakeholders. Collaborate cross-functionally with Clinical, Regulatory, Program Management, and Brand teams to ensure a coordinated approach to stakeholder engagement. Establish and maintain a KOL contact management database for internal use across Medical, Regulatory, and Commercial teams. Support the development of relationships with key advocacy groups to enhance pre-approval market development and post-approval adoption. Contribute to budgeting and financial planning for Medical Affairs activities and ensure adherence to approved budgets. Ensure compliance with industry regulations, including OIG, PhRMA, and ACCME guidelines. Requirements Minimum 5 years of experience in Medical Affairs within the pharmaceutical or biotechnology industry. Proven track record of engaging and developing KOLs, particularly within the US market. Experience in working with patient advocacy groups and fostering strong relationships. Advanced degree in Medicine, Pharmacy, or Life Sciences (MD, PharmD, PhD, or equivalent preferred). Understanding of regulatory and compliance requirements in Medical Affairs. Experience managing and maintaining KOL contact management databases . Background in gastrointestinal, osteoarthritis, or autoimmune diseases is a plus but not required. Ability to manage multiple projects, work cross-functionally, and thrive in a fast-paced environment. Willingness to travel 40-50% for conferences, meetings, and stakeholder engagements.
Job Title
Director Medical Affairs