Director, Clinical Supply Chain

Location
San Francisco, CA, United States
Posted
Aug 22, 2020
Ref
834
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
DIRECTOR, CLINICAL SUPPLY CHAIN

Position Summary:

This position is responsible for overseeing end to end global clinical supplies management for GBT small and large molecule clinical development programs, while continuing to develop organizational capabilities, processes and systems. The Director- Clinical Supply Chain will lead, manage and shape the vision of the clinical supply chain group by providing guidance and direction to the team. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed while placing a high value on cooperative team dynamics.

Essential Duties and Responsibilities:
  • Review, maintain and implement required Standard Operating Procedures (SOP's), business processes and systems needed to ensure effective operations
  • Leads department in establishing and executing clinical supply strategy for global clinical studies across GBT products lifecycle
  • Responsible for integrated forecasting and planning and supply strategies for the clinical supply chain. Perform modeling and scenario planning for short, medium and long-term range horizons. Integration with overall production planning process for GBT products
  • Oversee vendor activities related to packaging, labeling and distribution for GBT multinational clinical studies. Manage supply related areas related to IRT/IWRS systems and processes, including User Requirements (URS), User Acceptance Test (UAT)
  • Ensure global distribution and logistics processes are in place (Import/Export) for clinical supplies
  • Responsible for clinical labeling processes in compliance with applicable regulations, including processes around blinding, randomization, packaging design
  • Manage clinical supply inventory, expiry dates and inventory availability. Manage Jurisdictional Control process for clinical supplies
  • Develop, maintain and publish relevant Key Performance Indicators (KPI's)
  • Financial oversight of the clinical packaging and labeling vendors. Negotiates and evaluate costs and responsible for financial budgeting for clinical studies
  • Key contributor in Study Execution Teams (SET), Clinical Strategy Team (CST), and related CMC and organizational meetings. Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, Technical Operations/ CMC, Project Management to develop ideal supply strategies to support availability of product to patients
  • Hire, mentor and develop staff - foster environment of innovation and growth by providing clear vision and direction to team
  • Stays current with latest developments on regulatory and industry landscape and best practices on the clinical supply chain arena
  • Form and lead cross-functional teams as required. Maximize strength of team members
  • Timely and effective communication across functional areas, team, partners and any impacted stakeholders

Qualifications:
  • BS/BA degree in related discipline and/or twelve (12) years of related industry experience; or MS/MA degree in related discipline and ten (10) years of related experience, or equivalent combination of experience and education
  • Experience with regulatory submissions and active participation in Health Authority audits
  • Previous experience leading end to end clinical supply management required, including early phase, late phase as well as Investigator Sponsored Studies (IST's). Demonstrated experience with implementing procedures, building and shaping a clinical supply organization
  • Clinical supplies experience and knowledge in forecasting including demand and supply planning. Experience with implementing IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export and logistics
  • Strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13. In-depth understanding of CMC and manufacturing processes, Quality Assurance, Clinical Operations
  • Technical experience in manufacturing operations - drug product manufacturing, project management, packaging and labeling
  • Experience with regulatory submissions and participations in Health Authority audits
  • Supervisory skills, previous supervisory experience required
  • Experience with small and large molecule products

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.