Clinical Supply Chain Manager

17 hours ago

South San Francisco, California, United States Denali Therapeutics Full time
Job Title: Clinical Supply Chain Manager

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. We are seeking a highly skilled Clinical Supply Chain Manager to join our team.

Responsibilities:
  • Partner with Clinical Supply Chain Planning Lead to monitor production and distribution strategies for respective programs.
  • Serve as Supply Chain Execution point of contact with internal stakeholders.
  • Provide oversight to Denali's Finished Product supply chain vendors and facilitate execution activities.
  • Facilitate Label development, approval, and tracking.
  • Facilitate QP Declaration and Certification issuance and tracking.
  • Document and execute IRT transactions required to facilitate the release and distribution of product through the clinical supply chain.
  • Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.
  • Proactively identify and troubleshoot issues to prevent missed timelines.
  • Communicate status of supply execution activities both verbally and through written documents and reports.
  • Drive continuous operational performance improvement efforts.
  • Participate in supply chain business process development projects.
Requirements:
  • Bachelor's degree in Industrial Engineering/Operations/Supply Chain or related field.
  • 3+ years experience in clinical supply chain management or manufacturing in the Life Sciences.
  • Experience in vendor oversight and managing external partnerships and relations is preferred.
  • Experience working on cross-functional projects and business process definition/improvements is preferred.
  • Knowledge of IRT system setup and functionality is preferred.
  • Demonstrated ability to work accurately, meet timelines and handle multiple priorities.
  • Skilled in using influence management to drive project success.
  • Capable of responding flexibly to changing prioritization in a dynamic environment.
  • Strong interpersonal skills and ability to work with others in a positive 'can do' and collaborative manner.
  • Strong verbal and written communication skills.
  • Proficiency in MS Excel, Word, and PowerPoint.
  • Requires working knowledge of cGMP and regulations applicable to the FDA and comparable international regulatory agencies.

Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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