Vice President, Early Clinical Development
: Job Details :

Vice President, Early Clinical Development

Boston, MA, USA Req #311

Who We Are:

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 a Vice President, Early Clinical Development to join our team. The Vice President will lead all early development programs from drug candidate selection through to Phase 2 proof of concept. In addition, the Vice President will build the early development department including the pharmacology function to enable the design and efficient execution of all early development programs across multiple therapeutic areas including, epilepsy, psychiatry, and pain. Responsibilities will include providing strategic drug development input, provide clinical leadership to cross–functional teams and facilitate the execution of on-going and future early development 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:

• Lead the growing the early clinical development department at Xenon
• Provide strategic and clinical leadership to all early development programs across epilepsy, psychiatry, and pain programs
• Develop stage gated resource approach to account for the different phases of development for each program, including development of new processes where required
• Develop and implement new clinical pharmacology tools and technologies to drive smarter drug development for programs, where appropriate
• Represent the early department function and provide subject matter expertise to cross-functional project teams
• Develop and maintain collaborative working relationship with colleagues within and outside the department
• Author/review/approve clinical protocols, analysis plans, study reports and regulatory submissions
• Develop high quality early development and 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 early development 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 10-15 years or more of experience in appropriate disciplines that lay the foundation for to lead an early clinical development department
• Prior successful experiences in global regulatory interactions, including INDs, EOP1/2, and scientific advice
• Proven experience in leading and managing sophisticated and quantitative scientific teams
• Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process
• Hands on experience in design and executing a variety of phase 1 studies
• Strength in delivering results on agreed timelines in advancing Phase 1 studies and proof of concept studies
• Experience working in a matrix environment
• Appropriate publication records in top-tier and peer-reviewed journals are required to establish credibility with a highly talented scientific team
• Some US and international travel required

The base salary range for this role is $350,000 to $390,300 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge 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, including a Tuition Assistance program for advanced degrees.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge 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, including a Tuition Assistance program for advanced degrees. US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here .

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.

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