Associate Clinical Supply Chain Director

Exelixis•Alameda, CA

About The Position

The Associate Clinical Supplies Director designs, develops, and implements clinical supplies strategies, processes, and deliverables for clinical trials. The role manages supply planning and forecasting, and oversees clinical packaging, labeling, release, and distribution 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. The position independently manages clinical supply activities across multiple programs and study levels, including global supply strategies, inventory, worldwide distribution, label development, and IRT system development and testing. It represents Clinical Supplies at trial team meetings, communicates plans and timelines to stakeholders, and provides coaching and guidance to team members. The role has no supervisory responsibilities and involves approximately 20% travel to vendor sites, team meetings, and/or other offices.

Requirements

A BS/BA degree in a related discipline and at least 11 years of related experience; or an MS/MA degree in a related discipline and at least 9 years of related experience; or an equivalent combination of education and experience.
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.
Strong knowledge and demonstrated experience in clinical supply management, including planning, labeling, packaging, and distribution.
Knowledge of GMP batch record development, review, and approval processes.
Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities, and of GMP/GCP/GLP/GDP regulations.
Excellent oral and written communication skills and demonstrated stakeholder management skills.
Strong 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 forecasts and budgets for drug product and clinical supplies across multiple programs and study levels, based on clinical protocols and development plans.
Oversee clinical supply labeling, packaging, release, distribution, and returns at external CMOs, managing budgets and timelines.
Create global supply strategies and supply plans for clinical studies, collaborating with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors.
Manage clinical trial supply to ensure timely IMP production, inventory management, worldwide distribution, and uninterrupted supply.
Manage label development from creation of master label text through label printing.
Lead development, review, and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.
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 key project activities.
Provide coaching and guidance to team members.

Benefits

401(k) plan with generous company contributions
Group medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program, or a sales-based incentive plan for field sales staff
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