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Associate Director, Clinical Drug Supply

Employer
Enliven Therapeutics
Location
San Francisco, California, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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About the position:

Enliven is dedicated to advancing small molecule drug development programs in oncology. The Associate Director will provide day to day management of clinical supply products in support of all Clinical Development Programs. The individual in this role will be responsible for the global management of drug product supply for Enliven sponsored clinical trials as well as external collaborations. This position will work with both internal and external customers, suppliers, and CMOs to assist in development and communication of clinical supply project budgets, global supply plans, and processes to perform quality project execution, ensuring that all project objectives are met in a timely, efficient, and high-quality manner. The position will report into the Vice President of Clinical Operations.

Key Responsibilities:
  • Works with internal functions to create appropriate drug supply strategies, timelines, and project plans to meet requirements for Enliven sponsored clinical trials, investigator sponsored trials, and external partnerships/collaborations.
  • Manages and monitors the overall drug product inventory, ensuring appropriate supplies are ordered, maintained and distributed to clinical sites, based on industry standards and specific project requirements. Works with vendors to ensure accurate counts (physical inventory vs. virtual inventory records).
  • Coordinates with project teams to harmonize global drug supply labeling, including tracking required label updates and implementation according to regulatory timelines by geographic region.
  • Oversees logistics for bulk drug shipments between global contract manufacturing and depot facilities, including managing customs import/export activities.
  • Creates, reviews and modifies SOPs for Clinical Trials supply as well as create templates for use during clinical trials (pharmacy manuals, request forms, excursion forms, etc.)
  • Creates and manages clinical supply budget, tracking spending and accruals
  • Participates in the qualification and selection process for new clinical supply vendors, including contract labeling vendors, depots, transport carriers, and IRT systems.


Qualifications:

  • 10+ years of relevant experience in the pharmaceutical or health care industry or equivalent, and a Bachelor's degree, preferably in a scientific discipline, or 7+ years of relevant experience and a Master's degree
  • Direct experience in clinical trial supply activities is required
  • Good understanding of pharmaceutical compliance regulations, such as GMPs, GCPs, and GDPs
  • Ability to establish priorities and collaborate with the study team, cross functional team members and external partners/vendors
  • Strong interpersonal and negotiation skills
  • Good planning and organizational skills, coupled with strong time management skills
  • Core understanding of IRT system functionality is highly desired
  • Proven track record of being a strategic thinker and a tactical implementer.
  • Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast-learner and works well in an organization that places a high value on intellectual capacity.
  • Excellent written and oral communication skills.
  • Comfortable in an entrepreneurial organization wherein the environment is fast-paced and challenging.


Interested applicants, please send resume to: hr@enliventherapeutics.com

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

Enliven Therapeutics does not accept resumes from recruitment agencies for this position. Recruiters, please do not send resumes to Enliven employees or to the company location. Enliven is not responsible for any fees related to unsolicited resumes.
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