Senior Director, Clinical Development

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! The Sr. Director, Clinical Development will play a key role in the design and execution of ongoing and new clinical studies and contribute to the clinical development plan for one or more programs. The position will successfully lead and/or serve as the clinical science representative on one or more clinical studies (US and/or global) to deliver high quality data for registration. The position requires the ability to partner with Clinical Operations, Clinical Pharmacology, Regulatory, Early Development, Medical Affairs, Commercial and other stakeholders to deliver clinical programs for registration and launch. The successful candidate will have direct and recent experience in late phase clinical development, and in CRO and KOL interactions.    Responsibilities:   Provides clinical science leadership within assigned teams or programs  Manage the design, planning and execution of clinical trial program(s) as needed with minimal guidance  Is able to play a leadership role in subject matter expertise when interacting with global health authorities  Has deep familiarity with registration submission strategies and can manage the Clinical needs for all submissions as needed  Leads the study design, implementation and execution of clinical trials on assigned programs. Is responsible for the preparation of clinical study synopses and serves as a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports  Works cooperatively with project team members to provide clinical development expertise and leadership  Responsible for identifying and cultivating relationships with relevant national and international thought leaders to further project goals  In partnership with Regulatory Affairs and Project Management, oversee and ensure the quality, coordination and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing    Responsible for providing or supervising medical monitoring activities for all human clinical trials including support of adverse event reporting and safety management  Responsible for ongoing benefit/risk assessment, monitoring adherence to protocols, helping in the investigation of protocol deviations and providing leadership for monitoring activities related to execution of the protocol or program  Provides medical/clinical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents  Develops relationships with investigators and external organizations and experts to optimize study design and executions Requirements:   Doctoral level degree (PhD, MD, PharmD, PsyD) required   6+ years of relevant clinical development experience  Experience in CNS development (Psychiatry or neurology) strongly preferred  Possess strong knowledge of the clinical development process  Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business  Experience in small molecule development  Experienced in data review and analysis, presentations (internal and external) and regulatory writing (IND, CTD sections)  Experience building strong relationships within cross-functional groups to achieve results  Proven ability to identify and solve relevant problems related to clinical development  Experience in clinical research for psychiatry, addiction psychiatry, and addiction medicine programs, strongly preferred.  Background and proven relevant experience in engaging with clinical trial strategy and trial management  Understanding of the drug development process including technical, business, and regulatory issues.  IND experience strongly preferred  Diplomacy and professionalism, ability to build positive relationships both with company leadership and external experts Able to command respect from peers and subordinates, capable of highly independent work as well as being a team player and role model Excellent interpersonal, verbal and written communication skills  Proven ability to work remotely and with remote internal and external interdisciplinary teams  Problem-solving and strategic planning skills   Excited by innovative ideas in clinical research space  Self-motivated, resourceful with a ‘get the job done’ attitude in a fast-paced team environment  Other Skills:   Excellent writing and communication skills   Managerial skills a plus  Ability to handle obstacles and roadblocks by anticipating challenge