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Program Director, Tucatinib CMC

Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is ONT-380, an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.

Summary:

The Program Director, Tucatinib CMC will be responsible for leading CMC interactions and strategy development within the team environment at Cascadian Therapeutics. The individual will be a key player in interactions with all departments to support CMC activities for tucatinib. This role will also actively partner with all departments to communicate CMC requirements to team members both internally and externally. This key leadership role participates in multiple teams representing the Technical Operations group and also helps author regulatory US and ROW submissions, ensuring that they meet current regulatory standards, are high quality, consistent and complete.

Key Job Responsibilities:

  • Develops and executes CMC strategy in conjunction with other Technical Operations team members to cover all aspects from drug substance manufacturing through drug product presentation and supply.
  • Leverages the expertise of contract manufacturing partners and alliances.
  • Successfully communicates CMC status at all Tucatinib team meetings and to senior management.
  • Works closely with Research, Clinical Operations, Regulatory, Quality Assurance and Project Management to optimize execution of clinical development plans.
  • Ensures alignment of CMC activities with development and manufacturing plans. Chart the course, track progress against goals and outline key strategic events for project.
  • Creates viable solutions to any challenges and issues that arise, while keeping senior management informed.
  • Engages with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.
  • Builds solid communication with senior management to ensure alignment with corporate strategies. Coordinates efforts and facilitates communication of team members to address CMC needs effectively.
  • Enhances CMC related business process. Develops and updates strategy in response to changing business needs.
  • Leads the development of specific strategies to ensure successful development of CMC packages to support us and Rest of World registration and life cycle management.
  • Participates in due diligence teams as necessary.
  • Participates in various multi-disciplinary teams or taskforces related to CMC.
  • Interacts effectively with external business partners.
  • Conducts all efforts within budgetary and timeline boundaries.
  • Performs other duties and responsibilities as required.

Education / Experience / Professional Requirements:

  • Advanced degree (PhD or MS) in Chemistry, Chemical Engineering, Life Science or related major.
  • Minimum of 10+ years of applicable work experience within the pharmaceutical or biotechnology industry.
  • Strategic view and leadership abilities as well as hands on problem solving skills. Experience in managing projects is required.
  • Experience with staff management and/or CMC team management.
  • Ability to effectively work across all levels, functions, sites and companies.
  • Excellent verbal and written communication and presentation skills.
  • Experience in writing regulatory documents and submissions.
  • Advanced understanding of regulations governing manufacture of small molecule products.
  • Proven management skills.
  • Experience developing financial models and managing budgets.
  • Demonstrated proficiency in MS Office applications is required, including Project, Excel, Word, PowerPoint and Share Point.
  • Requires an ability and willingness for up to 10-20% domestic and international travel as necessary, consistent with the project needs.

Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.

If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».

We are an Equal Opportunity Employer