Executive Director, Clinical Pharmacology

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. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.


About the Role:


We are seeking an Executive Director, Clinical Pharmacology to join our team. The Executive Director will build the clinical pharmacology function to enable the design and efficient execution of all Phase 1 programs across multiple therapeutic areas including epilepsy, psychiatry, and pain. Responsibilities will include providing strategic drug development input, provide clinical pharmacology expertise to cross–functional teams and facilitate the execution of on-going and future Phase 1 programs at Xenon. In addition, the role will require the development of strong working relationships within Clinical Development Department and with other key functions including, for example, Pharmacovigilance and Drug Safety, Regulatory, Discovery, CMC, Translational, Trial Operations, Biostatistics and Program Management.
This position reports to the Senior Vice President, Clinical Development and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
• Continue to build the clinical pharmacology department to support Xenon’s expanding pipeline and transition to a cross functional matrix project model
• Provide strategic and clinical pharmacology leadership to all development programs across epilepsy, psychiatry, and pain programs
• Develop stage-gated and flexible financial and human resource approach to account for evolving requirements for each program
• Develop and implement new clinical pharmacology tools and technologies to drive smarter drug development for programs, where appropriate
• Represent the clinical pharmacology department function and provide subject matter expertise to cross-functional project teams
• Develop and maintain collaborative working relationships with colleagues within and outside the department
• Author/review/approve Phase 1 clinical protocols, analysis plans, study reports and regulatory submissions
• Develop high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, protocols and IBs etc.
• Develop and propose short- and long-term objectives for early clinical development in accordance with overall Company strategies and goals
• Plan and manage budget proposals and approved budgets in accordance with Xenon’s strategic and operating plans and Finance policies
• Build out the Clinical pharmacology department as the number of programs increase which includes recruiting, leading, directing, and developing direct reports, in accordance with the Company’s Human Resource policies and practices
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
• Some international travel may be required
• Other duties as assigned
QUALIFICATIONS:
• Ph.D. or MD with a minimum of 12 years of experience in clinical pharmacology roles of increasing leadership and scope
• Prior successful experiences in supporting global regulatory interactions, including INDs, EOP1/2, and scientific advice