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:
Responsible for developing and implementing departmental technical SOPs, business procedures and infrastructure to drive consistent and streamlined processes that improve business effectiveness.
Responsible for building 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.
Responsible for oversight of 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.
Oversees 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.
Supervisory Responsibilities:
Mentors teammates and leads in a matrix environment.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
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.
Has extensive experience in 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.
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.
Leads or manages the work of others by providing guidance based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Ability to interact with other key resources to develop a supply plan and facilitate it to completion.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.
Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
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.
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.
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