Senior Director, Clinical Supply Chain

Exelixis•Alameda, CA

7d•Onsite

About The Position

The Senior Director, Clinical Supply Chain 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 interfacing with CMC in developing clinical supply chain strategies ensuring availability of supply through development to commercial launch, as well as transferring sustaining activities during product development changes to the appropriate cross-functional teams to ensure continuation of supplies. Ensures uninterrupted supplies throughout the duration of a clinical study program based upon related targets and regulatory requirements.

Requirements

Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience.
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 experience in independently leading all aspects of clinical supplies management for Phase I, II and especially Phase III and Global trials as well as investigator sponsored trials (IST).
Demonstrated knowledge of manufacturing and production planning techniques and the tools used in the industry to streamline the planning process.
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.
Ability to make strategic decisions.
Ensures that team decisions align with organizational goals and that team members are empowered to make informed choices.
Demonstrated knowledge of manufacturing and production planning techniques and the tools used in the industry to streamline the planning process.
Working knowledge of GMP/GCP/GLP/GDP regulations required.
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
Able to contribute to the vision for continuous improvement across the organization.
Able to pioneer innovative improvement strategies and evaluate long-term efficacy.
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.
Ability to inspire a culture of delegation and accountability, ensuring alignment with organizational goals.
Ability to develop leaders.
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.

Responsibilities

Sets strategy 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.
Oversees 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.
Ensures monthly inventory reports are published for all product/studies.
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 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.
Ensures distribution arrangements are in place to allow shipment following availability of technical and regulatory releases.
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.
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Performs other duties as assigned
Complies with all policies and standards
Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions or terminations.
Manages others through subordinate supervisors.