Associate Clinical Supply Chain Director
Company: Exelixis
Location: King Of Prussia
Posted on: May 3, 2024
Job Description:
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:
- NoneEDUCATION/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 easeJOB
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.#LI-CW1If 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.DISCLAIMERThe 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.
Keywords: Exelixis, Cherry Hill , Associate Clinical Supply Chain Director, Professions , King Of Prussia, New Jersey
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