Senior Scientific Director, Medical Affairs

Definium Therapeutics

2d • $200,000 - $280,000

About The Position

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders by applying scientific rigor to psychedelics. Our lead product candidate targets anxiety, major depressive disorder, and PTSD, with a pipeline including a treatment for core symptoms of autism spectrum disorder. We aim to address the underlying causes of these disorders and transform mental health care. We are headquartered in New York and trade on Nasdaq under the symbol DFTX.

Requirements

• Advanced/doctoral degree in health sciences (PharmD, MD, PhD) required
• 10+ years of experience in CNS Medical Affairs including leadership roles and launch experience.
• Understanding of the medical affairs legal and regulatory environment
• Experience with project and vendor management
• Thorough understanding of CNS environment and key stakeholders
• Experience with Medical and Scientific review for both Promotional and Medical communications
• Experience and ability in working in a dynamic environment; excellent collaboration and communication skills
• Ability to demonstrate deep understanding of all medical affairs accountabilities

Nice To Haves

• Phase 4 experience desired but not preferred

Responsibilities

• Serve as the senior medical and scientific leader to generate and implement Medical Affairs strategy, maintaining the highest scientific rigor, and medical compliance.
• Serve as a Disease State expert as well as Medical Reviewer for MLR and Promotional review.
• Champion development and execution of the cross-functional Integrated Medical Affairs Plan, ensuring alignment with overall asset strategy and company goals.
• Maintain deep scientific and medical knowledge of CNS disease state including treatment landscape and clinical decision making.
• Work with publications and Medical Education leads, setting educational areas of interest for unsolicited continuing medical education grants, omnichannel approaches, and peer-to-peer programs.
• Proactively bring HCPs voice on cross-functional teams, to enable effective and impactful decision making.
• Identify data gaps to be addressed through an Integrated Data Generation Plan, set areas of interest for Investigator Initiated Studies, and partner with Health Outcomes and Economic Research to prioritize areas for real-world evidence generation.
• Provide training for internal staff on investigational and/or approved products, disease state and unmet needs.
• Assist with data generation, data analyses and interpretation as it relates to Phase 4 studies.
• Medical reviewer for Medical, Legal and Regulatory Committee and the Promotional Review Committee.
• Oversight and hands on support in generation and dissemination of clinical and non-clinical data that supports the medical strategy and results in high quality publications.
• Develop and cultivate long-term strategic partnerships representing Definium with clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders.
• Participate in developing and presenting medical content at congresses, symposia and advisory boards.
• Build strong, trusted partnerships across R&D, Regulatory Affairs (RA), Commercial, Legal, Market Access, patient advocacy and government affairs.
• Ensure adherence to global Medical Affairs standards and identify Medical policies, and processes as needed.
• As needed, Provide senior medical leadership and decision support for business strategy, innovation, and new product development across the Definium Portfolio.
• Ensuring alignment across regulatory, HEOR, commercial, and clinical priorities to support product lifecycle success.

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
• Some fun fringe perks

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree