Clinical Supply Chain Director

Exelixis Inc; Alameda (CA); On-site; USD 164,500 - 234,500; Full time

Benefits offered by this job

401(k) plan with company contributions

Medical, dental, and vision coverage

Life and disability insurance

Discretionary annual bonus program

Stock purchase program

Long-term incentives

Vacation and holidays

Job summary

Exelixis Inc is seeking a Clinical Supplies Director to lead the development and implementation of clinical supply chain procedures and infrastructure across small molecule and biologics programs.

You will oversee forecasting, labeling, packaging, distribution, and vendor oversight with GMP/GCP/GLP compliance while mentoring staff and collaborating with clinical, regulatory and procurement teams to ensure uninterrupted supplies through development and into launch.

Qualifications

• BS/BA with 13+ years, or MS/MA with 11+ years, or PhD with 8+ years
• Technical experience in drug product manufacturing, analytical testing/QC, and packaging/labeling operations
• Extensive experience implementing procedures and building clinical supply chain infrastructure
• Proven leadership of clinical supplies management for Phase I–III trials and investigator-sponsored studies

Responsibilities

• Develop and implement SOPs, procedures, and infrastructure for consistent processes
• Build vendor capabilities and oversee CMO vendors to meet Exelixis standards
• Oversee scheduling, labeling, packaging, randomization and distribution in GMP mode
• Perform short-, medium-, long-term supply forecast modeling
• Publish monthly inventory reports and manage inventories
• Mentor teammates and lead in a matrix environment

Skills

Clinical supply management

GMP/GCP/GLP knowledge

Analytical skills

MS Office proficiency

Vendor oversight

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Tools

MS Office

Job description

SUMMARY / JOB PURPOSE

The Clinical Supplies Director is responsible for developing and implementing clinical supply chain procedures and infrastructure to support the upcoming pipeline of both small molecule and biologics projects. They develop clinical supply chain strategies to ensure availability of supply through development and commercial launch and transfer sustaining activities to the appropriate site planning and procurement teams. This individual also ensures uninterrupted supplies throughout the duration of a clinical study program based upon related targets and regulatory requirements, and provides CMO vendor oversight.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop and implement departmental technical SOPs, business procedures, and infrastructure to drive consistent, streamlined processes that improve business effectiveness.
• Build vendor capabilities and knowledge to enable vendor selection; improve operational oversight at CMO vendors and ensure Exelixis standards are consistently implemented at each clinical supply chain vendor.
• Oversee scheduling and delivery of clinical supplies, including strategies for label and packaging design, randomization, packaging, labeling, and distribution in compliance with GMP regulations.
• Perform supply forecast modeling (short, medium, and long-term) and evaluate the impact of changing inventory targets, clinical demand, and budget restrictions.
• Publish monthly inventory reports for all products and manage inventories based on targets and regulatory filings (initial approvals and process changes in all countries).
• Oversee labeling, packaging, and distribution plans for each study, ensuring protocol requirements, regulatory requirements, blinding concerns, ease of handling, and patient compliance are met.
• Manage procurement of comparator drug products and matching placebo as required; prepare manuals for study drug, PK and PD samples.
• Ensure distribution arrangements are in place for shipment following availability of technical and regulatory releases; oversee record maintenance, protocol evaluation, coding of samples, and storage of approved materials.
• Maintain batch records and clinical supplies database.
• Collaborate with Pharmaceutical Sciences functions, Clinical and Non-Clinical Teams, and vendors for the strategic sourcing of vendors to support the development supply chain.
• Mentor teammates and lead in a matrix environment.

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS

• BS/BA degree in a related discipline with a minimum of thirteen years of related experience; or MS/MA with at least eleven years; or PhD with at least eight years (or an equivalent combination of education and experience). Certification in the assigned area may be required.
• Technical experience in drug product manufacturing, analytical testing/QC, and pharmacy packaging/labeling operations as required to meet FDA guidelines.
• Extensive experience implementing procedures and building infrastructure of a clinical supply chain function.
• Demonstrated knowledge of manufacturing and production planning techniques and the tools used in the industry to streamline the planning process.
• Proven experience independently leading all aspects of clinical supplies management for Phase I, II, and especially Phase III trials as well as investigator-sponsored trials.
• Working knowledge of GMP/GCP/GLP regulations.
• Strong knowledge and demonstrated experience of clinical supply management – planning, labeling, packaging, and distribution.
• Experience in either in-house facilities or at a CMO.
• Ability to interact with other key resources to develop a supply plan and facilitate its completion.
• Excellent analytical and business communication skills; proficiency with MS Office and specialized applications.

JOB COMPLEXITY

Works on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues that require evaluation of intangibles. Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.

WORKING CONDITIONS

• 20% travel to vendor sites, team meetings, and other offices.

COMPENSATION & BENEFITS

• Base pay range: $164,500 - $234,500 annually (adjusted for geographic region).
• 401(k) plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock purchase program.
• Long‑term incentives.
• 15 accrued vacation days in the first year.
• 17 paid holidays, including a companywide winter shutdown in December.
• Up to 10 sick days per calendar year.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: [e-mail].