Medical Director/ Senior Medical Director

Accepting BioReady™: Yes
Category: Senior Management
Education: Master
Experience: 0-3 Years
Location: Vancouver, BC
Posted: May 13, 2022
Closes: June 13, 2022

Job description:

Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders.

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us.  We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.

The Medical Director/Senior Medical Director is key contributor to clinical development of the Company’s portfolio of products and product candidates from Discovery to Phase 3 and potentially post-approval, focusing on medical input, monitoring and safety.

The Medical Director/Senior Medical Director will have medical knowledge of neurology and preferably epilepsy and epilepsy therapeutics, relevant drug development experience, be a strong self-starter and have a highly collaborative approach to working with others across a range of Discovery, Clinical Development and Commercial functions. The Medical Director/Senior Medical Director 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.

The position reports to the Vice President, Clinical Development and will be located in either the Vancouver, BC, Canada or Boston, MA, USA; we may consider other locations for an exceptional candidate.

RESPONSIBILITIES:

• Contribute to the strategic development of early and late-stage clinical programs.

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution, and communication of a global clinical trial(s).

• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.

• Participate and provide clinical input into safety and regulatory interactions.

• Interpret and communicate clinical trial data.

• Author CSRs, publications, and regulatory submissions.

• Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings, and external committee meetings.

• Identify new clinical research opportunities.

• Support in-licensing and out-licensing activities and partner relationships.

• Support product lifecycle management for new indications as directed.

• Provide clinical content input to materials to be used in Medical/Scientific Affairs and Commercial.

• International travel may be required.

• 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.

• Other duties as required.

• 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.

QUALIFICATIONS:

• MD or MD/PhD with strong and versatile clinical development experience, preferably with experience in depression.

• Minimum 2 years industry experience, prefer 5+ years at Senior Medical Director level.

• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.

• Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials: experience with clinical trials from concept to clinical study report highly desirable.

• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.

• Leadership experience/potential as a medical expert in a complex matrix environment.

• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.

• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path.

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