Senior Director/Executive Director, CMC, Drug Substance

Boston, MA, USA ● Vancouver, BC, Canada Req #95 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.

We are seeking a Senior Director/Executive Director, CMC Drug Substance to join our team. The Senior Director/Executive Director, CMC Drug Substance manages and oversees the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for deployment in early- and late-stage clinical trials and commercial distribution. The Senior Director/Executive Director will be a key member of a highly collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns through contract development and manufacturing organizations (CDMOs).
 
The Senior Director/Executive Director, CMC Drug Substance will have proven leadership ability in a fast paced, multi-location environment and will have a strong track record of productive interactions with all levels of internal staff as well as external stakeholders including, but not limited to, consultants and CDMOs. In addition, this role will require someone who is hands-on, and manage a small team.

This position reports to the Vice President, Product Development and Operations, and will be located in either the Vancouver, BC, Canada or Boston, MA, USA metropolitan areas; we may consider other locations for an exceptional candidate.
  RESPONSIBILITIES:

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards
• Evaluate, recommend and manage qualified CDMOs for the manufacture of API for clinical trials as well as for commercial use
• Serving as the subject matter expert, manage and oversee audits and inspections of API CDMOs in conjunction with Quality Assurance
• Collaborating closely with the internal process chemistry team, manage API process technology transfer to the Company’s CDMOs, including process validation and the establishment and refinement of suitable specifications for APIs
• Work closely with Supply Chain and CMC Drug Product colleagues to translate demand forecasts (both clinical and commercial) into API manufacturing plans
• Author (in conjunction with Technical Writing) and/or act as a key reviewer of core CMC documents/modules and other forms of submissions and responses to FDA and other Competent Authorities providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto
• Maintain current knowledge of issues relevant to pharmaceutical development, drug development, Competent Authority regulations and guidance, as well as competitive trends to inform input and recommendations
• Plan and manage API-related budget proposals and approved project budgets in accordance with the Company’s strategic and operating plans and Finance policies
• Recruit, lead, direct, develop, coach and evaluate 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 Intellectual Property policies. Ensure that policies are understood and followed by direct reports

QUALIFICATIONS:

• PhD in Chemistry or other relevant discipline with a minimum of 12 years of directly-related experience in a pharma or biotech environment. Candidates with a MSc and relevant experience may be
• Extensive experience in managing development-stage and commercial-stage API manufacturing activities conducted at CDMO
• Experience in acting as strategic lead for key CMC sections in U.S. NDA and European MAA filings for small molecule API
• Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to API
• Experience with CDMO selection, vendor management, contracting, issue resolution and management
• Excellent oral and written communication, leadership and interpersonal skills as well as the ability to build credibility and trust inside and outside the Company
• Proven ability to build and develop high performing teams; excellent delegation and conflict resolution skill
• Be science- and data-driven while at the same time, creative and flexible in strategic thinking and problem solving
• Ability and willingness to travel up to 15% of the time, both domestically and internationally