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Bicara Therapeutics, a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation, is seeking a Director of Medical Affairs Operations to lead the strategic and tactical execution of the Medical Affairs department. Based in Boston with a hybrid schedule (3 days in-office weekly), this role reports to Medical Affairs leadership and oversees all operational aspects of the department.
Key responsibilities include operationalizing the annual medical affairs strategic plan, managing vendor onboarding, purchase orders, and budget forecasting. You will lead Investigator-Sponsored Trial (IST) operations including budget tracking, drug material planning, and publication management. The role encompasses Medical Education Grants and Sponsorship activities, advisory board strategy and logistics, and cross-functional collaboration with Commercial, Compliance, IT, Finance, Clinical Development, and Legal teams.
You will drive comprehensive budget management across forecasting, annual operating plans, and accruals, ensuring accurate tracking for corporate reforecasting cycles. Creating and maintaining dashboards for Medical Affairs, launch initiatives, and board-level reporting is essential. The position requires conducting periodic capability assessments, implementing process improvements, and maintaining SharePoint infrastructure and standard operating procedures (SOPs) across all functional groups.
Additional responsibilities include Veeva systems administration, CRM reporting collaboration with field medical affairs, compliance monitoring, and ensuring 100% audit readiness for all medical affairs programs. You will demonstrate strong project management, vendor management, and cross-functional leadership capabilities.
Required qualifications: Bachelor's degree (health-related field preferred; advanced degree preferred), 8+ years of program management experience in biotech or pharmaceutical industry with strong Medical Affairs understanding, proven launch experience, demonstrated leadership and project management skills, and ability to influence across organizational levels. Up to 20% travel for conferences and meetings.
