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:- BS/BA degree in related discipline and a minimum of seven years of related experience; or,
- MS/MA degree in related discipline and a minimum of five years of related experience; or,
- Equivalent combination of education and experience.
- Certification in assigned areas is a plus.
Experience/The Ideal for Successful Entry into Job:- Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution.
- Clinical Supply management experience using contract manufacturing companies strongly preferred.
- Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS
Knowledge/Skills:- Willingness 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.
- Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
- May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Exercises 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.
Work Environment/Physical Demands:Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $132,500 - $188,000 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.
