Senior Director, Medical Affairs Operations and Strategy

Definium Therapeutics is a late-stage clinical biopharmaceutical and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.  

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.     

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. 

Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

Responsibilities:

• 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 deelop materials that that align with regulatory requirement and industry best practices
• Implement and refine operational governance frameworks for scientific review and medical communication standards
• Ensures 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

Skills and Competencies:

• Strong understanding of Global Medical Affairs functions and their interconnections with other departments
• Technical knowledge in Veeva CRM, Veeva Vault, KOL Mapping Systems, etc.
• Excellent project management skills with the ability to manage initiatives simultaneously
• Demonstrated ability to work effectively with cross-functional teams in changing environments
• Innovative mindset with the ability to identify and implement creative solutions for global challenges

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 activites. 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

The starting base pay range for this position is $269,204.00 - $295,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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!