SUMMARY/JOB PURPOSE: The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials.
This individual also manages clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, and distribution operations at contracted manufacturing organizations (CMOs).
The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
Essential Duties And Responsibilities: Create and manage clinical forecast plans and budgets related to drug product, and clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical development plans.
Oversee the labeling, packaging, release, distribution and returns of clinical supplies at external CMOs for the assigned studies, maintaining budget and ensuring that the projects are delivered on time.
Create global supply strategies, supply plans to support clinical studies; collaborate with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.
Manage clinical trial supply to ensure timely IMP production; manage inventory and worldwide distribution activities; ensure uninterrupted supply.
Manage label development process from generation of the master label text to label printing.
Lead the development, review and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.
Co-lead the development of pharmacy documents, manuals and other tools with Clinical Operation team.
Represent Clinical Supplies function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.
Utilize appropriate software and IT systems (e.g.
IRT, MS Office, MS Project, Smartsheets, and others) to effectively manage key project activities.
Provide coaching and guidance to team members.
Supervisory Responsibilities: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in related discipline and a minimum of eleven years of related experience; or, MS/MA degree in related discipline and a minimum of nine years of related experience; or, Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job: 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) Experience with IRT systems for drug supply management.
Clinical Supply management experience using contract manufacturing companies strongly preferred.
Knowledge/Skills: Strong knowledge and demonstrated experience in clinical supply management- planning, labeling, packaging and distribution Strong initiative and desire to work in a fast-paced team-oriented, and dynamic environment.
Creativity and flexibility in problem solving; work collaboratively as part of a team Knowledge of GMP batch record development, review, and approval processes Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
Working knowledge of GMP/GCP/GLP/GDP regulations Excellent oral and written communication skills; along with strong demonstrated stakeholder management skills Excellent project management and organizational skills; ability to plan and execute multiple on-going projects with ease JOB COMPLEXITY: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Exercises good business and technical judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Networks with key contacts outside own area of expertise.
Working Conditions: 20% travel to vendor sites, team meetings, and/or other offices.
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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across severalU.S.
geographic markets, and we pay differently based on those defined markets.
The base pay range for this positionis $152,000 - $215,000 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.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers 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.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and 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.