Definium Therapeutics logo

Definium Therapeutics

Senior Director, Medical Affairs Operations and Strategy at Definium Therapeutics

RemoteFull-timeRemote27 - Medical AffairsPosted 21 days ago

About the Role

<div class="content-intro"><p>Definium Therapeutics&nbsp;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.&nbsp;&nbsp;</p> <p>Our lead&nbsp;product&nbsp;candidate,&nbsp;lysergide&nbsp;tartrate&nbsp;(our&nbsp;proprietary orally disintegrating tablet form of&nbsp;lysergide&nbsp;(LSD) D-tartrate),&nbsp;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.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p> <p>Guided by&nbsp;the recognition&nbsp;that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address&nbsp;the&nbsp;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.&nbsp;</p> <p>Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!</p></div><p><strong>Responsibilities:</strong></p> <ul> <li>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</li> <li>Oversee and ensure the quality of the departmental strategic planning processes, including operations tasks, and other activities related to pipeline compounds</li> <li>Leads organization, updating and communication of strategic plans to internal and external stakeholders</li> <li>Foster strong partnerships with internal teams such as Clinical Development, HEOR, Commercial teams, &amp; finance to ensure alignment and efficiency in medical activities</li> <li>Develop, maintain, and update Medical Affairs SOPs and quality documentation to support compliant, efficient, and consistent operations</li> <li>Work in close collaboration with Compliance, Regulatory, and Legal counterparts to deelop materials that that align with regulatory requirement and industry best practices</li> <li>Implement and refine operational governance frameworks for scientific review and medical communication standards</li> <li>Ensures material development for internal and external use is aligned with organizational goals and priorities and meets compliance, regulatory, and legal requirements</li> <li>Establish and oversee project management frameworks for all MA initiatives, including medical launches, clinical collaborations, evidence-generation programs, and scientific communication outputs</li> <li>Monitor timelines, risks, and deliverables; provide transparent reporting to leadership on progress and resource needs</li> <li>Coordinates cross-functional project teams to ensure timely execution and integration of medical insights into decision-making</li> <li>Maintenance of program budget trackers and financial forecast for Medical Affairs programs</li> <li>Implement and optimize systems and tools to enhance productivity and data management</li> <li>Develop and track key performance indicators (KPIs) to measure the effectiveness Medical Affairs operations</li> <li>Collaborate with IT to implement and optimize technology solutions for medical operations</li> <li>Serve as a liaison between Global Medical Affairs and other departments to facilitate smooth operations and communication across regions</li> </ul> <p><strong>Skills and Competencies:</strong></p> <ul> <li>Strong understanding of Global Medical Affairs functions and their interconnections with other departments</li> <li>Technical knowledge in Veeva CRM, Veeva Vault, KOL Mapping Systems, etc.</li> <li>Excellent project management skills with the ability to manage initiatives simultaneously</li> <li>Demonstrated ability to work effectively with cross-functional teams in changing environments</li> <li>Innovative mindset with the ability to identify and implement creative solutions for global challenges</li> </ul> <p><strong>Requirements:</strong></p> <ul> <li>Doctorate degree (PharmD, MD, DO, PhD)</li> <li>10 plus years of industry experience with demonstrated high-level professional knowledge and skills in the areas of medical affairs and R&amp;D</li> <li>Experience in both pre launch and post-launch medical affairs activites. Experience with Psychiatry/CNS is a plus</li> <li>Demonstrated ability to create and lead successful cross-functional teams in changing and competitive environments</li> <li>Experience with Early Access Programs (EAP) is a plus</li> <li>Candidates must be comfortable working independently in a fast-paced environment</li> </ul> <p></p> <p>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.</p> <p>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:</p> <ul> <li>100% paid health benefits including Medical, Dental and Vision for you and your dependents</li> <li>401(k) program with company match and vesting after the turn of the first month after your start date</li> <li>Flexible time off</li> <li>Generous parental leave and some fun fringe perks!</li> </ul> <p></p>