Manager, Clinical Supply Coordination

Reports To: Vice President, Chemistry and Manufacturing

Job Description

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.

Principal Duties and Responsibilities

• 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

Education & Experience

• 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