Clinical Supplies Manager II

Exelixis Inc; Alameda (CA); On-site; USD 132,500 - 188,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Group medical, dental, and vision coverage

Paid vacation days

Discretionary annual bonus

Job summary

Exelixis Inc in Alameda is seeking a Clinical Supplies Manager II to oversee all aspects of clinical supply management including packaging, labeling, and distribution. The ideal candidate will manage supply activities, collaborate with stakeholders, and ensure compliance with applicable regulations.

With a focus on maintaining project timelines, you will leverage your expertise in clinical supply management and IRT systems. This role offers significant responsibilities and opportunities to shape project outcomes in a supportive work environment.

Qualifications

• Minimum of seven years of related experience; or five years with MS/MA.
• Demonstrated experience with clinical supply management.
• Working knowledge of GMP/GCP/GLP regulations required.

Responsibilities

• Oversee clinical supply management including packaging and distribution.
• Monitor clinical supply activities from start-up through closure.
• Partner with stakeholders to ensure compliant labeling and release.

Skills

Project management

Communication skills

Clinical supply management

GMP regulations

IRT systems knowledge

Education

BS/BA degree in related discipline

MS/MA degree in related discipline

Job description

Summary / Job Purpose

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

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 and a minimum of five years of related experience; or an equivalent combination of education and experience.

Certification: Certification in assigned areas is a plus.

Experience: 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

30% travel to vendor sites, team meetings, and/or other offices. Work environment: modern, open-plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. Provides all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

Benefits

Base pay range for this position is $132,500 - $188,000 annually (adjusted by geographic region). In addition to base salary, total rewards program includes 401(k) plan with company contributions, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus program, and options for company stock. Accrued vacation days 15 in first year, 17 paid holidays including winter shutdown in December, up to 10 sick days.

Equal Opportunity Employer

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.