The Opportunity:Playing a critical role within the Pharmaceutical Development and Manufacturing (PDM) organization, the position will be responsible for planning and delivering clinical supplies to support RevMed's clinical development programs.
- Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan.
- Plan and deliver on-time, compliant clinical supply per the clinical development plan.
- Collaborate with cross-functional teams (i.e. Clinical Operations, QA, PDM, and Regulatory) to ensure continued advancement of the clinical programs.
- Lead and manage clinical supply and logistics activities, for blinded as well as open label studies, including but not limited to: demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
- Author, review, and/or approve related clinical and technical documents, including but not limited to: clinical label text, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA.
- Support vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution.
- Conduct necessary training and develop/improve required SOPs.
Required Skills, Experience and Education:- B.S. or M.S. in scientific fields with 8+ years of experience in clinical supply chain and logistics.
- Working knowledge of import and export laws and processes.
- Working knowledge of pharmaceutical drug product development and manufacturing.
- 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.
- Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.
Preferred Skills: - Strong experience managing clinical supply activities for global phase 3, randomized, oncology clinical trials.
- Experience managing a team, directly or in a matrix setting.
#LI-CT1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Base Pay Salary Range
$186,000-$233,000 USD
