Director, Commercial & Medical Legal Counsel at Definium Therapeutics

<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>The Commercial &amp; Medical Counsel will act as a strategic partner to commercial and medical affairs teams, helping translate complex regulatory requirements into practical guidance that enables compliant commercialization. We are looking for a personable legal advisor with an understanding of the False Claims Act; Food, Drug &amp; Cosmetic Act; Anti-Kickback Statute; and other healthcare laws and regulations. You will have high visibility throughout the organization, supporting core business activities and providing counsel to cross-functional teams. You will be empowered to develop strong and positive working relationships with colleagues at all levels. Experience in pharmaceutical / life sciences advising, ability to work in a fast-paced environment, and willingness to be a flexible, business-oriented team player are required. The role reports to the Associate General Counsel.</p> <p><strong>&nbsp;Responsibilities</strong></p> <ul> <li>Provide day-to-day legal counsel to Sales, Marketing, Market Access, Medical Affairs, HEOR and Patient Advocacy teams, advising on a broad range of regulatory matters, including labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients</li> <li>Participate as a core member of promotional and medical MLR Review Committees, and advise on advertising, promotion, and scientific exchange</li> <li>Advise on interactions with healthcare professionals, payers, patients, and patient advocacy organizations, and help identify and mitigate compliance risks</li> <li>Review and/or draft contracts for compliance with relevant regulatory standards</li> <li>Ensure compliance with all relevant laws, regulations, policies, procedure and controls within relevant business areas supported</li> <li>Develop and deliver training for business partners on legal and compliance issues</li> <li>Communicate legal advice to business stakeholders in an authentic and understandable way</li> </ul> <p><strong>Requirements:</strong></p> <ul> <li>Juris Doctorate and admission to practice law in at least one state</li> <li>Minimum 5 years legal experience, including experience advising pharmaceutical or other life sciences clients is required. In-house pharmaceutical industry experience is preferred</li> <li>Understanding of applicable laws and regulations, particularly FDA promotional guidance, the Anti-Kickback Statute and False Claims Act, the PhRMA Code, and relevant HHS-OIG guidance</li> <li>Strong interpersonal skills and ability to present complex information accurately and concisely to influence others at all levels of management</li> <li>Experience with state price reporting, transparency reporting or privacy matters preferred</li> <li>Ability to provide clear, actionable guidance in a fast-paced environment and handle multiple, conflicting priorities and time-sensitive situations</li> <li>High degree of professional ethics and integrity</li> </ul> <p>The starting base pay range for this position is $217,877.00 - $260,733.00. 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>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p>