Director, CMC, Drug Product

We are seeking a Director, CMC, Drug Product to join our team. The Director, CMC Drug Product will help manage and oversee the development and manufacturing of cGMP drug product (oral solid dosage) for deployment in mid-and late-stage clinical trials and commercial distribution. The Director will be a key member of a highly collaborative internal CMC team, primarily managing drug product development programs and manufacturing campaigns through Xenon’s network of contract development and manufacturing organizations (CDMOs).

This position reports to the Senior Director, CMC, Drug Product  and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required. This role is a hybrid position, requiring a minimum of 2 days per week in the office

RESPONSIBILITIES:

• Manage and oversee the development and manufacturing of clinical and commercial drug product in accordance with applicable quality and regulatory standards.
• Evaluate, recommend and manage qualified CDMOs for the manufacture of drug product for clinical trials (Phase 2/3), as well as for commercial use.
• Serving as the subject matter expert, participate in audits and inspections of drug product CDMOs in conjunction with Quality Assurance.
• Collaborating closely with the preformulation team, manage drug product process tech transfer to the Company’s CDMOs, including process validation and the establishment and refinement of suitable specifications for drug product.
• Work closely with Supply Chain and CMC Drug substance colleagues to translate demand forecasts (both clinical and commercial) into drug product 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.
• 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.
• 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 domestic and international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• PhD in Chemistry, Pharmaceutical Sciences or other relevant discipline with a minimum of 10 years of directly-related experience in a pharma or biotech environment. Candidates with a MSc and significant relevant experience may be considered as well
• Demonstrated track record in successfully managing development-stage and/or commercial-stage Drug product manufacturing activities conducted at CDMOs
• Strong knowledge and deep understanding of solid oral dosage form development and associated modern processing technologies
• Experience authoring/co-authoring key CMC sections in U.S. NDA and European MAA filings for small molecules
• Extensive knowledge of cGMP-related regulations, guidance documents, principles and best practices pertinent to drug product
• Experience with CDMO selection, vendor management, contracting, issue resolution and management
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel and experience in applying risk-based decision-making tools
• Excellent oral and written communication and interpersonal skills as well as the ability to build credibility and trust inside and outside the Company
• Excellent attention to detail and commitment to providing accurate, high quality work
• Good organizational skills and the ability to manage multiple competing priorities
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team
• Be science- and data-driven while at the same time, creative and flexible in strategic thinking and problem solving

The base salary range for this role is $214,700 to $229,300 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.