Senior Medical Director, Clinical Development (Psychiatry)

Job Description

Senior Medical Director, Clinical Development (Psychiatry) Boston, MA, USA Req #330 Thursday, January 16, 2025 Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. About the Role: We are seeking a Senior Medical Director, Clinical Development to join our team. This incumbent is a key contributor to clinical development of the Company’s portfolio of products and product candidates from Discovery to Phase 3 and post-approval activities, focusing on leadership of clinical studies and programs as required, medical leadership, and medical and safety monitoring (as Medical Monitor) for assigned company’s products. The Senior Medical Director, Clinical Development will have medical knowledge of psychiatry and preferably neurology, recent development advances in psychiatric therapeutics landscape, relevant drug development experience, be a collaborative, inspirational, resilient leader, have a broad strategic view of therapeutic area and be well-versed in high-quality trial execution. The ability for a highly collaborative approach to working with others across a range of Discovery, Clinical Development, and Commercial functions is an expectation. The Senior Medical Director, Clinical Development will interact with all levels of internal staff as well as external stakeholders, including, but not limited to Key Opinion Leaders, Advisory Boards and Committees, and Health Authorities. This position reports to the Vice President, Clinical Development, Psychiatry and will be located in Boston, MA, USA; we may consider other locations for an exceptional candidate. RESPONSIBILITIES: Lead and manage clinical development studies in psychiatry, including design and medical oversight throughout clinical development stages in collaboration with internal colleagues. Serve as medical monitor (MM) and interact collaboratively with clinical research sites and investigators globally. Contribute to the preparation and ongoing revisions and strategy of Clinical Development Plans for assigned products and product candidates. Provide strategic and scientific leadership for trial designs. Review scientific literature and develop product and indication knowledge. Serve as therapeutic area expert to provide scientific input into clinical trial(s). Maintain a high degree of awareness of the external research and regulatory environments. Identify and build relationships with KOLs and other experts. Draft and/or review clinical and scientific sections of regulatory submissions. Participate in the review and interpretation of clinical trial data. Provide analyses of development strategies and options for discovery pipeline programs. Support in-licensing and out-licensing activities. Present proposals and plans to various audiences. Contribute to the development of short- and long-term goals for the department. Participate in the planning and management of budget proposals. Recruit, lead, direct, develop, coach, and evaluate direct reports. Act in accordance with Company policies. Other duties as assigned. QUALIFICATIONS: MD or MD/PhD with strong clinical development experience, ideally in psychiatry. Minimum 8-12 years progressive development experience in the pharmaceutical industry. Minimum 12+ years of relevant management experience. Knowledge of pharmaceutical product development and commercialization processes. Experience with developing study concepts for clinical development. Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations. Growth mindset and leadership potential. Ability to effectively present ideas and document complex medical/clinical concepts. Strong interpersonal skills and problem-solving abilities. The base salary range for this role is $318,500 to $352,200 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including education, qualifications, and experience. Our Total Rewards program includes base salary, target bonus, stock options, and a full range of benefits. Xenon encourages time to rest and recharge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program. To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted. #J-18808-Ljbffr