Associate Director / Director, Medical Operations
About The Position
The Associate Director/Director, Medical Operations is responsible for leading the strategic planning, execution, and continuous improvement of operational processes that enable an effective and compliant Medical Affairs function. This role partners closely with Medical Affairs leadership, Finance, Clinical Development/Operations, Regulatory, Patient Advocacy, and external vendors to optimize workflows, manage key systems and vendors, and ensure high-quality execution of medical activities (e.g., publications, medical information, advisory boards, and investigator-initiated studies, where applicable). This role is ideal for a proactive and adaptable leader who thrives in a fast-paced, evolving biotech environment. Success requires balancing strategy and execution, strong stakeholder management, and the ability to build scalable, compliant operational solutions. This role will be based in our Lexington, MA office with a hybrid work arrangement.
Requirements
- Bachelor’s degree in life sciences or related field required; post-baccalaureate degree preferred
- Associate Director: 8–10+ years of experience, including Medical Affairs/Operations, or Director: 10–15+ years of experience with leadership responsibility
- Experience in small to mid-size biotech environment preferred
- Global Medical Affairs exposure
- Experience in scaling operations in growing biotech environments
- Launch experience and Medical Affairs build-out preferred
- Vendor RFP and management experience
- Strong knowledge of Medical Affairs activities and compliance requirements
- Experience with systems such as Veeva CRM and Medical Information platforms
- Excellent project management and organizational skills
- Data-driven mindset with reporting and analytics experience
- Strong cross-functional leadership and communication skills
- Ability to operate strategically and execute tactically
Responsibilities
- Design, implement, and optimize operational processes supporting Medical Affairs activities (e.g., publications, medical communications, field medical operations, medical information)
- Oversee execution and tracking of key deliverables, ensuring timelines, budgets, and quality standards are met
- Establish and manage Medical Affairs KPIs, dashboards, and reporting
- Lead vendor selection, onboarding, and oversight, and manage budgets and forecasts
- Serve as business owner for Medical Affairs systems and tools
- Partner cross-functionally with Clinical, Regulatory, Legal, Compliance, Patient Advocacy, and IT
- Ensure compliance with GxP and company SOPs; support audits and inspections
- Support strategic planning and continuous improvement initiatives
Benefits
- company-sponsored medical, dental, vision, life, long and short-term disability insurances
- generous paid time off (including a week-long company shutdown in the Summer and the Winter)
- 401K participation with matching contributions
- Employee Stock Purchase Program
- discretionary annual bonus
- discretionary stock-based long-term incentives
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
