Director/Senior Director, Pharmacovigilance and Drug Safety
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy. Xenon has a number of promising therapeutics in clinical development, valuable collaborations with pharmaceutical partners, and innovative early-stage research underway and also has a strong balance sheet to support its continued growth in 2020 and beyond.
We are a collaborative, ambitious, and driven team with a common mission to improve the lives of patients with neurological disorders. Creating a healthy and productive work environment is a priority, and we understand the importance of investing in our employees’ growth and development. We support charities and volunteerism, knowing that when our people contribute to their local communities, they are gaining new experiences and becoming even better leaders. Xenon’s employees are smart, passionate, and driven by their incredibly important work to discover, develop and deliver new medicines for patients in need. We are looking for talented and determined individuals who thrive in a fast-paced and dynamic work environment to join our team during this transformative time for the company.
We are seeking a Director/Senior Director, Pharmacovigilance and Drug Safety to join our team. The Director/Senior Director will be a key member of Xenon’s Clinical Development team. They will lead and manage the Pharmacovigilance and Drug Safety function for all products and product candidates globally, act as a key contributor to clinical development plans, and manage all relevant reporting to global health regulatory authorities.
This role will initially be very hands on, with frequent cross-functional collaboration and excellent working relationships with many internal groups, including, for example, Clinical Science, Non-clinical, Biometrics, Clinical Operations, Regulatory, Medical Affairs and Senior Executive Management, with the opportunity to build a team in accordance with progress of the Company’s products and product candidates. The incumbent will play a key role in helping to establish and maintain external relationships with Key Opinion Leaders (KOL) and other experts to ensure appropriate input is sought at all stages of development.
This position initially reports to the Chief Medical Officer and will be located in Boston, MA, USA location: we may consider other locations for an exceptional candidate.
- Lead, guide and manage the safety aspects of clinical development plans for all product candidates in all stages of development, ensuring that appropriate drug safety techniques and principles are incorporated, particularly risk/benefit profile considerations.
- Initially act as global pharmacovigilance physician, reviewing all clinical trial safety data, and preforming trend analysis to identify any emerging safety concerns; in future, may lead and manage pharmacovigilance physicians and specialists.
- Author, review and/or approve the preparation of relevant sections of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) and other regulatory documents and other documents, including, for example, clinical protocols, Statistical Analysis Plans (SAPs), clinical study reports, Investigator Brochures (IBs).
- Collaborate with other key internal functions to interact with health regulatory authorities, to seek advice and respond to queries, both in writing and in-person.
- Author Safety Monitoring and Risk Management Plans; manage Date Safety Monitoring Board (DSMB) activities as required.
- Ensure that medical and causality assessments of all clinical adverse event filings to foreign regulatory authorities are consistent with Company policy and relevant regulatory requirements globally.
- Develop and manage post-marketing surveillance and reporting activities for relevant products in relevant jurisdictions in accordance with product strategic and commercialization plans.
- Review safety data of non-clinical studies to inform clinical development strategies and plans, including dose escalation protocols.
- Collaborate with Clinical Science and Medical Affairs to develop publications and clinical data communications; review scientific publications such as posters, abstracts, and manuscripts.
- Represent the Company at scientific and medical meetings, including, for example, Investigator Meetings, Advisory Boards, commercialization partners and potential partners.
- Develop department team, standards, processes, and infrastructure in accordance with overall company strategy, clinical development, and commercialization plans.
- Present proposals and plans to variety of audiences, including to the Company’s Senior Executive Team
- Develop and propose short- and long-term goals for the department in accordance with overall Company and Development strategies.
- Maintain professional knowledge and U.S. accreditation by active participation in continuing medical education activities.
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
- Occasional international travel required.
- Other duties as required from time to time.
- 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.
- MD with a minimum of 8 years of progressive clinical development experience, preferably in pharmacovigilance, at a pharmaceutical or biotechnology company.
- Broad experience in clinical trial design (Phase 1 to 3) and clinical data interpretation.
- Working knowledge of FDA and EMA regulatory landscapes, GCP, and ICH guidelines.
- Excellent verbal communication and presentation skills.
- Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment.