Associate Clinical Supply Distribution Director

Exelixis Inc; Alameda (CA); On-site; USD 167,000 - 237,000; Full time

Benefits offered by this job

401(k) plan

Comprehensive benefits package

Employee stock purchase program

Paid holidays

Vacation days

Job summary

Exelixis Inc. is seeking an Associate Clinical Supply Distribution Director to lead global logistics for the clinical supply chain. You will set up depot networks, ensure regulatory compliance, and oversee temperature-controlled shipments with vendor oversight.

The role demands extensive experience in international pharmaceutical logistics, GMP knowledge, and strong stakeholder management to support uninterrupted supply to clinical sites and patients.

Qualifications

• BS/BA in related discipline with 11+ years experience or MS/MA with 9+ years experience.
• Technical experience in international pharmaceutical logistics and supply chain.
• Knowledge of GMP and regulatory requirements for clinical distribution.
• Strong communication and stakeholder management skills.

Responsibilities

• Oversee logistics and distribution of clinical supplies, ensuring GxP compliance.
• Manage import/export documentation, transit documents, and customs clearances.
• Partner with Trade Compliance and manage VAT/tax considerations.
• Act as Process Owner for site shipments, temperature monitoring and vendor oversight.
• Develop country requirement databases and KPI-driven vendor governance.
• Identify opportunities to improve service and performance with governance models.

Skills

GxP compliance

Regulatory knowledge

Cold chain mgmt

Vendor management

Data analysis

MS Office

Documentation

Stakeholder mgmt

Education

BS/BA in related discipline

MS/MA in related discipline

Tools

MS Office

Specialized clinical logistics software

Job description

SUMMARY/JOB PURPOSE: The Associate Clinical Supply Distribution Director is responsible for implementing global logistics and distribution strategies for the clinical supply chain. Focused on delivering uninterrupted availability of supply to clinical sites and patients by setting up depot network, complying with international import and export guidance, shipment execution including shipper solutions and transit temperature monitoring device utilization and vendor oversight. Function as area Subject Matter Expert.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsible for oversight of logistics and distribution of clinical supplies, ensuring compliance with GxP regulations. Comply with regulatory requirements, maintain proper documentation, including transit documents and customs clearances. Partner with Trade Compliance expert and support to ensure processes for proper customs valuation, VAT/tax management and reclamation, and risk management through INCO terms Process Owner for site-by-site shipment of drug product, importation document management, temperature excursion management, Returns/Destruction/Reconciliation Oversee the maintenance and compilation of distribution data to assist in budget creation and adherence Liaise with clinical operations and clinical supply chain project team regarding project issues and resolution SME partnering with vendors and internal and external industry experts to develop and maintain a database of country requirements, including import and export requirements, Health Authority lead times, transit lead times and country/region specific considerations to support effective start-up and maintenance of clinical supply chain. Identify opportunities to improve overall service and performance of current vendors by working within governance models and through regular communications and established KPIs.

SUPERVISORY RESPONSIBILITIES

Supervises staff

EDUCATION / 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: Technical experience in international pharmaceutical logistics and supply chain Experience in the pharmaceutical and biotech industries.

Knowledge/Skills: Strong knowledge and demonstrated experience in clinical supply 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 Working knowledge of regulations relating to clinical supply distribution activities. Working knowledge of GMP regulations Excellent oral and written communication skills; along with strong demonstrated stakeholder management skills Demonstrated technical skills and mindset in logistic and cold chain management including process optimization and delivery of drug product Experience with pharmaceutical supply chain requirements and international trade compliance laws and regulations including but not limited to, imports, exports, Harmonization Tariff system (HTS), country of origin, valuations for customs declarations, dangerous goods guidelines Demonstrated experience in maintaining a database of import data in full compliance with reporting requirements of US Customs Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.

JOB COMPLEXITY: WORKING CONDITIONS: Primarily working indoors in an office environment 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.

#LI-MB1 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 $166,500 - $236,500 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. If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

WORKING CONDITIONS: Our office is a modern space that fosters collaboration 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. 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. 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.