Clinical Supply Chain Manager

Location
Brisbane, California, United States
Posted
Sep 11, 2020
Ref
209049606
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference.

If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

Summary:
This person reports to the Associate Director of Clinical Supply Chain. This role will allow the ideal person to be exposed to new methodologies.

Essential Functions

These may include, but are not limited to, the following; other duties may be assigned:
  • Develop clinical study supply plans and maintain active inventory tracking for both clinical and placebo investigational drug products in compliance with company's internal procedures and GxP requirements.
  • Prepare clinical trial material forecasts at the study level and track material inventory, update use and expiry dating to ensure uninterrupted delivery of clinical study supplies. Proactively highlights to management when action is indicated. "Actions" may include a shelf life extension or resupply submission to health authorities as necessary.
  • Have experience and understanding of IRT (Interactive Response Technology) systems and trial execution using these systems.
  • Participate in global clinical drug supply activities associated with the team's trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies)
  • Vendor Management - Prioritize labelling and packaging activities at CROs/CMOs, when packaging operations for clinical trial material are in-process.
  • Establish the packaging design based on protocol and manage all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors
  • Ability to coordinate CTM shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites
  • Ability to coordinate courier deliveries and shipments, and manage the courier relationship. Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP
  • Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives.
  • Participates on clinical sub-teams and provides clinical supply updates and summaries to management. Supports management with implementation of departmental strategies and policies.

Qualifications
  • BS or Master's Degree in life science, or related field (or equivalent experience)
  • 4-6 years' experience in GMP clinical supply chain, supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization.
  • Preferably Certificate in Supply Chain Management Program
  • Ability to work independently to make strategic decisions related to planning, and budgeting.
  • Understanding of cGMP's and pharmaceutical industry procedures and regulations
  • Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience
  • Hand on experience with Interactive Response Technology (IRT)
  • Strong, open and transparent communication skills (verbal and written)
  • Solid organizational and time management skills
  • Project management skills and computer proficiency
  • Experience with: MS Office Suite
  • Ability and willingness to travel 10% of the time (internationally and domestically)