Director, Medical Affairs Operations

Position Overview

Responsibilities

• Operationalize annual medical affairs strategic plan and provide operational support for medical affairs programs
• Manage vendor onboarding process, purchase order generation for new/existing vendors and agencies, and tracking and forecasting
• Routinely and consistently track IST study timelines and all publications (planned & actual)
• Ensure draft publications are processed through review and timely feedback provided to investigators
• Lead Medical Education Grants and Sponsorship activities within medical affairs with cross-functional collaboration
• Follow through on process with decisions communicated and follow up as needed for these activities
• Work with Medical Affairs leadership to create annual advisory board strategy, manage advisory board logistics, contracting, vendor sourcing, and working with legal/compliance
• Drive budget management in areas of forecasting, annual operating plan, and actual accruals
• Create and update cross-functional launch and project-specific dashboards for MA, including slide decks for BoD meetings, dashboard reporting etc.
• Conduct periodic assessments of Medical Affairs capabilities, processes, and systems to identify gaps and opportunities for improvement
• Implement with leadership, platform/processes to drive efficiencies and provide robust reporting capabilities
• Administrator for SharePoint for assigned projects as needed; developing site/folder structure, internal review, and site content
• Responsible for development and maintenance of SOPs for all medical affairs functional groups and activities
• Ensure compliance with SOPs across all activities, identification and appropriate escalation of issues/risks, and responsible for 100% audit readiness for medical affairs programs
• Responsible for maintaining Veeva systems within medical affairs and working cross-functionally for appropriate workflows within systems
• Collaborate with field medical affairs for CRM reporting activities and create dashboards for leadership view with business operations colleagues

Qualifications

• Bachelor’s degree, preferably in a health-related field; advanced degree preferred
• 8+ years’ program management experience in biotech or pharmaceutical industry and strong understanding of Medical Affairs function
• Launch experience is strongly preferred
• Prominent leadership skills with demonstrated project management proficiency and a positive approach in managing staff, vendors, and project related issues
• Must be a team player with strong self-awareness and excellent interpersonal skills
• Demonstrated ability to influence others and to successfully lead in a cross-functional environment
• Ability to travel up to 20% for conferences and meetings

Company Overview

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients.

For more information, please visit www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Career Level: Mid-Senior Level

Compensation Range: $223K - $259K