Senior Director, Medical Affairs Operations – Strategy

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Definium Therapeutics

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2019

🧬 Biotechnologie

💊 Pharmaceutique

Biotechnology • Pharmaceuticals

Definium Therapeutics est une entreprise de biotechnologie en phase clinique qui développe des thérapeutiques dérivées de substances psychédéliques pour des troubles psychiatriques et neurodéveloppementaux. La société se concentre sur des formulations pharmaceutiquement optimisées de lysergide (LSD) et un énantiomère R de MDMA pour traiter des conditions telles que le trouble dépressif majeur, le trouble anxieux généralisé, et les symptômes principaux du trouble du spectre autistique, faisant progresser les candidats à travers les essais précliniques et cliniques avec une approche dirigée par la science et soutenue par des preuves.

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

🎯 Exigences

• 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.

🏖️ Avantages

• 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!