Definium Therapeutics is a late-stage clinical biopharmaceutical company 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!
As Senior Scientific Director, Medical Affairs, you will serve as the senior medical and scientific leader to generate and implement Medical Affairs strategy, maintaining the highest scientific rigor, and medical compliance. You will 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
Advanced/doctoral degree in health sciences (PharmD, MD, PhD) required
12+ years of experience in CNS Medical Affairs including leadership roles and launch experience. Phase 4 experience desired but not preferred
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
The starting base pay range for this position is $200,000.00 - $280,000.00. 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!
Originally posted by Definium Therapeutics. View original posting
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