Exelixis Inc
Associate Director, Clinical Supplies (Finance)
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Job Description
The Associate Director (AD), Clinical Supplies will design, develop, and implement the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials. This individual will also manage 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 will partner with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensure timely drug supply for clinical trials.
Qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Create and manage clinical forecast plans 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, and distribution of clinical supplies at external CMOs for the assigned studies, ensuring that the project timelines are met.
• Review clinical trial protocols and understand impact on clinical supplies.
• Forecast clinical trial supply to ensure timely IMP production.
• Monitor inventory levels (depot and sites); take preventative actions to prevent potential supply issue
• Manage label development process from generation of the label text to label printing.
• Lead the development, review and acceptance testing of IRT.
• Collaborate with Clinical Operations to continuously confirm current demand assumptions (i.e., enrollment rate, number of sites, number of countries, and timelines) to create/update supply plans; ensure seamless coordination of demand and supply.
• Co-lead the development pharmacy documents, manuals and other tools with Clinical Operation team.
• Coordinate US and international distribution and logistics with CMOs.
• Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.
• Utilize appropriate software and IT systems to effectively manage key project activities.
• Provide coaching and guidance to team members.
SUPERVISORY RESPONSIBILITIES:
• Manage direct reports as required.
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and at least ten years of related experience; or,
• MS/MA degree in related discipline and at least eight years of related experience; or,
• Equivalent combination of education and experience.
• Certification in assigned areas is a plus.
Experience:
• Demonstrate experience with clinical supply management planning, labeling, packaging, and distribution.
• Clinical Supply management experience using contract manufacturing companies strongly preferred.
Knowledge/Skills/Abilities:
• Ability to work in a fast paced, evolving environment.
• Knowledge of GMP batch record development, review, and approval processes. Knowledge of Interactive Voice/Web response systems for use in clinical studies.
• Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
• Working knowledge of GMP/GCP/GLP regulations required.
• Excellent project management and communication skills.
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.
• Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.
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Additional Information
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.