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Associate Director, Clinical Supply Chain - CMC

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Industry: Biotechnology
  • Post Date: 02/06/2023
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Drive, Redwood City, CA, 94063
  • Salary Range: $50,000 - $150,000

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients. Our innovative product engine draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.

Job Description

REVOLUTION MEDICINES is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Playing a critical role within CMC, the position will be responsible for clinical supply chain and logistics-related activities in support of clinical program(s) with clinical trials at various phases (Phase I-III).

The Opportunity:

  • Develop and execute a clinical supply plan for the clinical program(s) assigned, including but not limited to demand and supply forecast, packaging and labeling of trial supplies, distribution plan based on global import/export requirements, and region/country-specific release requirements for the investigational product, and inventory management

  • Review of User Requirements Specification (URS), the performance of User Acceptance Testing (UAT), and maintenance of IRT system, as applicable.

  • Author, review and/or approve related technical documents such as, but not limited to: clinical label text, clinical/master batch records, clinical trial protocols, pharmacy manuals, IND, IMPD, and NDA.

  • Assist vendor identification and qualification of the secondary packaging and distribution vendors based on clinical product requirements.

  • Interface with cross-functional teams (Clinical Operations, QA, CMC, Project Management, etc.) to ensure timely support of the projects.

  • Conduct necessary training, and update/develop required SOPs.

  • Lead commercial supply planning and product launch, as required.

  • Lead commercial labeling and packaging site evaluation and selection, as required.

 

Required Experience, Skills, and Education:

  • B.S. or M.S. in scientific fields with 8+ years of experience in pharmaceutical supply chain and logistics.

  • Strong experience managing supply chain activities for US and/or global clinical trials including managing and overseeing labeling and packaging vendors and supply depots.

  • Working knowledge of import and export laws and processes.

  • Working knowledge and experience in supporting randomized global clinical trials.

  • Working knowledge and experience in oncology trials are a plus.

  • Working knowledge and experience in pharmaceutical drug products in terms of manufacturing and design are a plus.

  • Working knowledge and experience in commercial packaging design and serialization are a plus.

  • Solid organizational and time management skills.

  • Effective, open, and transparent communication skills (verbal and written).

  • Capable of working on multiple projects/tasks and able to meet timelines.

  • Experience in building and maintaining drug forecast and distribution trackers and/or clinical inventory management systems.

  • Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

 

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.

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