Clinical Supply Chain Director

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. Also responsible for developing clinical supply chain strategies ensuring availability of supply through development and commercial launch, as well as transferring 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 in addition to providing CMO vendor oversight.

Essential Duties And Responsibilities

• Develops and implements departmental technical SOPs, business procedures and infrastructure to drive consistent and streamlined processes that improve business effectiveness.
• Buils vendor capabilities and knowledge to enable vendor selection.
• Improves operational oversight at CMO vendors and ensures Exelixis standards are consistently implemented at each clinical supply chain vendor.
• Oversees scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations.
• Performs supply forecast modeling (short, medium and long-term).
• Ensures product requirements and costs for the budget are complete and in place for assigned projects. Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions. Publishes monthly inventory reports for all products.
• Manages the inventories based upon targets and various regulatory filings (initial approvals and process changes in all countries).
• Oversees activities relating to the labeling, packaging, and distribution plans for each study (e.g., bulk drug products, matching placebo, PK/PD samples, etc.) based on protocol requirements and factors such as regulatory requirements, blinding concerns, ease of handling by the sites and patients, and patient compliance.
• Manages the procurement of comparator drug products and matching placebo as required.
• Helps prepare needed manuals for study drug, PK and PD samples.
• Ensures distribution arrangements are in place to allow shipment following availability of technical and regulatory releases.
• Manages the record maintenance, protocol evaluation, coding of samples, and storage of approved materials. Ensures that batch records and clinical supplies database are maintained.
• Works collaboratively with other Pharmaceutical Sciences functions, Clinical and Non-Clinical Teams in the strategic sourcing of vendors to support the development supply chain.

Mentorship

Mentors teammates and leads in a matrix environment.

Education/Experience

• BS/BA degree in related discipline and a minimum of thirteen years of related experience; or,
• MS/MA degree in related discipline and a minimum of eleven years of related experience; or,
• PhD in related discipline and a minimum of eight years of related experience; or,
• Equivalent combination of education and experience.

May require certification in assigned area.

Experience/The Ideal For Successful Entry Into Job

• Technical experience, in drug product manufacturing, analytical testing/QC, and Pharmacy packaging, and labeling operations as required in meeting FDA guidelines.
• Demonstrated knowledge of manufacturing and production planning techniques and the tools used in the industry to streamline the planning process.
• Demonstrated experience in independently leading all aspects of clinical supplies management for Phase I, II and especially Phase III trials as well as investigator sponsored trials (IST).
• Working knowledge of GMP/GCP/GLP regulations required.

Knowledge/Skills

• Strong knowledge and demonstrated experience of clinical supply management – planning, labeling, packaging and distribution.
• Clinical Supply operations experience either in in-house facilities or working at a CMO is required.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Led or managed the work of others by providing guidance based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Able to interact with other key resources to develop a supply plan and facilitate it to completion.
• Creates formal networks involving coordination among groups.

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 where analysis of situations or data requires an evaluation of intangibles.

Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.

Creates formal networks involving coordination among groups.

Working Conditions

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

Compensation

The base pay range for this position is $164,500 - $234,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

Benefits

• Comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Opportunity to purchase company stock, and receive long-term incentives.
• Up to 10 sick days throughout the calendar year.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. 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.