Director, Medical Affairs Operations

Position Overview

Bicara Therapeutics is seeking a Director, Medical Affairs Operations who will support the strategic direction and oversee the tactical execution of operations for the Medical Affairs department. This will include the development and execution of strategic plans, oversight of contracting activities, creation of dashboards and managing multiple projects concomitantly. This position will work cross-functionally with other leaders and functions (including all Medical Affairs functions, Commercial, Compliance, IT, Finance, Clinical Development and Legal) to drive from inception to completion all Medical Affairs workstreams and projects and to provide relevant medical input on the strategic and tactical support. The ability to work with and influence stakeholders across all levels will be essential.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

For an exceptional candidate, the level of this role may be adjusted commensurate with experience and qualifications.

Responsibilities

• Operationalize annual medical affairs strategic plan and provide operational support for medical affairs programs, including but not limited to managing vendor onboarding process, purchase order generation for new/existing vendors and agencies, tracking and forecasting as necessary.

• Lead IST Operations including tracking budget, drug material planning and forecasting with supply chain.

• 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 the 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 ad board logistics, contracting, vendor sourcing, working with legal/compliance.

• Drive budget management in areas of forecasting, annual operating plan and actual accruals. Ensure accurate and up to date budget tracking which feeds into periodic corporate budget reforecasting and annual projections for program budgets.

• 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.

• Proven 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.