Associate Director, Clinical Supply Chain
New
J
JobgetherPharmaceuticals
Based in United StatesFull-TimeDirector
SalaryExpected salary range of $170,000–$204,750, depending on skills, competency, and market demand.
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Job Details
- Experience
- 10+ years of relevant experience with a Bachelor's degree, or 8+ years of experience with a post-graduate degree.
- Required Skills
- GCPMicrosoft ExcelPowerPoint
Requirements
- 10+ years of relevant experience with a Bachelor's degree, or 8+ years of experience with a post-graduate degree.
- Demonstrated clinical supply chain experience, with additional exposure to Manufacturing, Quality, and/or Regulatory functions.
- Strong knowledge of global clinical trials, the drug development lifecycle, and clinical supply chain processes.
- Experience working in GxP environments with an understanding of global pharmaceutical regulations (cGMP, GCP, 21 CFR Part 11, Annex 13).
- Proven ability to build strategic relationships and collaborate with Clinical Operations, Quality, CMC, and Regulatory teams.
- Strong experience managing external supply partners, packaging, labeling, distribution, and logistics providers.
- Highly developed influencing, negotiation, and stakeholder management skills.
- Excellent communication, organizational, problem-solving, and project management skills.
- Expert proficiency in Microsoft Excel and PowerPoint.
- Experience using project planning tools such as Microsoft Project and Office Timeline.
Responsibilities
- Translate clinical trial assumptions into drug forecasts, supply plans, and distribution strategies.
- Lead end-to-end clinical supply execution and serve on CMC and Study Management Teams.
- Manage clinical supply budgets and coordinate payments for contract manufacturing organizations.
- Oversee secondary packaging, labeling, and final drug release activities.
- Provide supply-related input to RTSM requirements and oversee system maintenance.
- Identify and mitigate end-to-end supply chain risks, including country backups and inventory levels.
- Partner with Clinical Operations, Quality, and Regulatory teams to support IND, IMPD, and CTA submissions.
- Manage quality-system documentation, including deviations, investigations, CAPAs, and change controls.
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