Reports To: Vice President, Chemistry and Manufacturing
The Clinical Supply Manager will be a member of the CMC team interfacing heavily with Clinical Operations to support preparation of clinical trial materials. This position will report to the Vice President of Chemistry and Manufacturing.
- Work with Clinical Operations to forecast CTM needs, develop clinical supply plans, packaging configurations and distribution strategies
- Provide supporting documents and supplies as well as mock kits, labels and/or inserts as needed to assist Clinical Operations in study planning
- Develop labeling to meet study and regulatory requirements
- Provide supply forecasts and requirements to the CMC team to ensure appropriate delivery schedules of drug product for clinical use
- Work with manufacturing monitors and CMOs to create and review packaging plans, resolve issues and support the packaging activities
- Interact as needed with other clinical service providers
- Represent clinical supply issues within the CMC planning group and on cross functional teams
- Manage a dynamic environment, creating options and strategies to meet needs and/or schedules as they evolve
- Assist Clinical Operations as needed in distribution, handling complaints, returns and destruction of CTM
- Other activities as requested
- Limited travel
- Degree in related science area
- Ability to develop timelines and monitor activities required to meet clinical study needs
- Working knowledge of clinical cGMPs and regional regulatory requirements for clinical materials and labels
- 3+ years experience clinical supply logistics and/or clinical packaging
- Excellent team skills
- Good written and verbal communication skills
Human Resources
Medivation, Inc.
201 Spear Street
3rd Floor
San Francisco, CA 94105
hr@medivation.com
