Associate Clinical Supply Chain Director

Exelixis•Alameda, CA

1d•$161,000 - $228,000

About The Position

The Associate Clinical Supplies Director designs, develops, and implements clinical supplies strategies and processes to meet clinical trial supply deliverables. The role manages clinical supply planning and forecasting and oversees clinical packaging, labeling, release, distribution, and returns at contracted manufacturing organizations (CMOs). The Associate Director partners with leaders in CMC, Regulatory Affairs, Clinical Operations, and Quality Assurance to support study teams and ensure timely drug supply for clinical trials. The position creates supply forecasts, budgets, and global supply plans across programs and study levels; manages inventory and worldwide distribution; and oversees timely investigational medicinal product (IMP) production. It also manages label development, leads development and user acceptance testing of Interactive Response Technology (IRT) systems, and co-leads pharmacy documents and tools with Clinical Operations. The role represents Clinical Supplies at trial team meetings, communicates plans and timelines to stakeholders, uses relevant project software and IT systems, and provides coaching and guidance to team members. The position has no supervisory responsibilities and requires 20% travel to vendor sites, team meetings, and/or other offices. The office is described as a modern, collaborative workspace equipped with dual monitors and ergonomic chairs. Compensation is $161,000–$228,000 annually, adjusted by geographic region and other job-related factors. Benefits include a 401(k) plan with company contributions, medical, dental and vision coverage, life and disability insurance, flexible spending accounts, eligibility for a discretionary annual bonus or applicable sales incentive plan, company stock purchase opportunities, long-term incentives, 15 accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days per calendar year.

Requirements

Bachelor of Science/Arts degree in a related discipline and at least 11 years of related experience; or a Master of Science/Arts degree in a related discipline and at least 9 years of related experience; or an equivalent combination of education and experience.
Strong knowledge and demonstrated experience in clinical supply management, including planning, labeling, packaging, and distribution.
Experience independently leading all aspects of clinical supplies management for Phase I, II, and especially Phase III trials, as well as investigator-sponsored trials.
Experience with IRT systems for drug supply management.
Knowledge of GMP batch record development, review, and approval processes.
Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities.
Working knowledge of GMP, GCP, GLP, and GDP regulations.
Excellent oral and written communication skills and demonstrated stakeholder management skills.
Excellent project management and organizational skills, including the ability to plan and execute multiple ongoing projects.
Strong initiative and desire to work in a fast-paced, team-oriented, dynamic environment.
Creativity and flexibility in problem solving, and ability to work collaboratively as part of a team.

Nice To Haves

Clinical supply management experience using contract manufacturing companies is strongly preferred.

Responsibilities

Create and manage clinical supply forecasts and budgets for drug product and clinical supplies across multiple programs and study levels, based on study protocols and clinical development plans.
Oversee labeling, packaging, release, distribution, and returns of clinical supplies at external CMOs, maintaining budgets and timelines.
Develop global supply strategies and plans for clinical studies, collaborating with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors.
Manage clinical trial supply, including timely IMP production, inventory, and worldwide distribution, to ensure uninterrupted supply.
Manage label development from creation of master label text through label printing.
Lead development, review, and User Acceptance Testing (UAT) of IRT systems.
Co-lead development of pharmacy documents, manuals, and other tools with the Clinical Operations team.
Represent Clinical Supplies at clinical trial team meetings and communicate plans and timelines to internal and external customers and partners.
Use appropriate software and IT systems, including IRT, MS Office, MS Project, and Smartsheets, to manage project activities.
Provide coaching and guidance to team members.

Benefits

401(k) plan with generous company contributions
Group medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
Flexible spending accounts
Eligibility for a discretionary annual bonus program or, for field sales staff, a sales-based incentive plan
Opportunity to purchase company stock
Long-term incentives
15 accrued vacation days in the first year
17 paid holidays, including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year