Clinical Supplies Manager II

SUMMARY / JOB PURPOSE :

The Clinical Supplies Manager II oversees all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners / vendors to ensure supply of IMP are sufficient at depots and clinical sites.

Essential Duties And Responsibilities :

• Lead effort for clinical supply management functionality.
• Monitor and manage clinical supply activities through IRT from study start-up through study closure.
• Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO's for assigned studies, ensuring the project timeline is met or exceeded.
• Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases.
• In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan.
• Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials.
• Work cross-functionally to develop IRT to develop specifications and perform UAT.
• Design and / or review label text to meet product requirements and ensure compliance with US and international regulations.
• Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.
• Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors.
• Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness.
• Utilize appropriate software and IT systems to effectively manage key project activities.

Supervisory Responsibilities :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

Knowledge / Skills :

JOB COMPLEXITY :

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#LI-MB1

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 $121,500 - $172,000 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.