Senior Director, Medical Affairs Operations – Strategy

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🕒 April 20

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• 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!