Senior Director, Medical Affairs Operations – Strategy
Definium Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $269,204 - $295,000 per year
Job Level
About the role
- In collaboration with Medical Affairs leadership, develop, operationalize, and continuously refine the Medical Affairs strategy, helping to translate strategic objectives into actionable project plans, KPIs and timelines
- Oversee and ensure the quality of the departmental strategic planning processes, including operations tasks, and other activities related to pipeline compounds
- Leads organization, updating and communication of strategic plans to internal and external stakeholders
- Foster strong partnerships with internal teams such as Clinical Development, HEOR, Commercial teams, & finance to ensure alignment and efficiency in medical activities
- Develop, maintain, and update Medical Affairs SOPs and quality documentation to support compliant, efficient, and consistent operations
- Work in close collaboration with Compliance, Regulatory, and Legal counterparts to develop materials that align with regulatory requirements and industry best practices
- Implement and refine operational governance frameworks for scientific review and medical communication standards
- Ensure material development for internal and external use is aligned with organizational goals and priorities and meets compliance, regulatory, and legal requirements
- Establish and oversee project management frameworks for all MA initiatives, including medical launches, clinical collaborations, evidence-generation programs, and scientific communication outputs
- Monitor timelines, risks, and deliverables; provide transparent reporting to leadership on progress and resource needs
- Coordinates cross-functional project teams to ensure timely execution and integration of medical insights into decision-making
- Maintenance of program budget trackers and financial forecast for Medical Affairs programs
- Implement and optimize systems and tools to enhance productivity and data management
- Develop and track key performance indicators (KPIs) to measure the effectiveness Medical Affairs operations
- Collaborate with IT to implement and optimize technology solutions for medical operations
- Serve as a liaison between Global Medical Affairs and other departments to facilitate smooth operations and communication across regions
Requirements
- Doctorate degree (PharmD, MD, DO, PhD)
- 10 plus years of industry experience with demonstrated high-level professional knowledge and skills in the areas of medical affairs and R&D
- Experience in both pre launch and post-launch medical affairs activities. Experience with Psychiatry/CNS is a plus
- Demonstrated ability to create and lead successful cross-functional teams in changing and competitive environments
- Experience with Early Access Programs (EAP) is a plus
- Candidates must be comfortable working independently in a fast-paced environment.
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
strategic planningproject managementKPI developmentcompliance documentationoperational governancescientific reviewmedical communicationdata managementfinancial forecastingcross-functional team leadership
Soft Skills
collaborationcommunicationorganizational skillsproblem-solvingadaptabilityindependencerelationship buildingleadershiptransparencyefficiency
Certifications
Doctorate degreePharmDMDDOPhD