Job details

Associate Director, Supply Chain (Clinical Supplies)

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Job Description

Associate Director, Supply Chain (Clinical Supplies)

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Job Overview:

The Clinical Supplies Associate Director is an end-to-end clinical supplies leader that inspires teams while providing expertise in a fast-paced biopharmaceutical clinical supplies environment for Gilead’s global clinical trials. The Associate Director works internally with other members of Global Supply Chain and External Manufacturing and other functions (Development Operations; Clinical Operations; Formulation and Process Development; Device Development and Clinical Package Engineering; Quality Assurance; Regulatory; and Project Management partners), to develop and formulate strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.

Job Responsibilities:

Supports the development of supply strategy while working collaboratively to oversee supplies for clinical developmental portfolio and ensure on-time delivery of investigational medicinal product (IMP) to initiate and resupply clinical studies (e.g., CSCM Rep in PDM Sub-Team);
Influence decision-making at cross-functional teams (Clin Ops, PDM-sub teams); CSCM sub-team rep for typically (1+) developmental programs- able to take on programs of greater complexity
Collaborate with other CSCM, PDM leaders, and external vendors & partners to resolve shipping relate issues and implement long term solutions/changes
Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, auditing, onboarding, management, contract negotiation, issue resolution, risk mitigation, and continuous improvements.
Participates in program allocations decisions and influences and negotiates partner performance. Identifies areas where process improvements are imperative and influence cross-company change.
Recognizes gaps in internal procedures to new pending regulations and mobilizes the team to develop plans to close gaps. Influences cross-functionally to implement industry best practices.
Authors revises, and reviews SOPs, Work Instructions, and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance; influence cross-functional SOP content and review/approve as required.
Responsible for maintaining a culture of GDP, GMP, and global trade compliance
Obtain and review quotes, and approves purchase requisitions and invoices. Participates in the departmental budgeting process - forecasts labeling and distribution expenses, and estimate headcount requirements.

Management Responsibilities:

Establishes direction and sets priorities, creates clear work plans for staff; communicates progress regularly;
Manage multiple levels of people including staff and managers
Recruits, onboards, develops, retains, and supervises staff; sets clear goals for individuals and the group

Knowledge and Skills:

Possess strong clinical supplies management experience/ knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations
Possesses strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs.
Possesses experience with clinical blinding practices in global study, from Phase 1 to Late Phase.
Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy.
Expert knowledge of the FDA, cGMP, GCP standards and regulatory guidance documents
Able to support regulatory inquiries both face-to-face, and via email, with appropriate professional responses.
Leads through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines
Excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error free documents/presentations. Must be a confident communicator and presenter to all organizational levels.
Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus.
Able to manage the resources and timelines for a team with multiple studies with different complexities simultaneously

Education and Experience:

10+ Years with BA/ BS OR 8+ Years with MA/ MS/MBA OR 2+ Years with PHD or PharmD
A BA degree in a science related field OR MS, PharmD, or MBA highly preferred..
Prior experience in complex, oncology trials is highly preferred.

We offer you the opportunity to work within a culture of highly motivated, talented individuals who are dedicated to the company's mission. Each job provides wide-ranging responsibilities due to our cross-functional organizational structure and leadership style, which ensures that everyone is engaged, committed and accountable

We are looking for individuals from diverse backgrounds who want to work together and support each other to help make a real difference in the lives of patients - people who thrive on performing well within a challenging and fast-paced environment, living our core values of Integrity (always doing the right thing), Teamwork (collaborating in good faith), Excellence (working at a high level of commitment and capability), Accountability (taking personal responsibility) and Inclusion (Encouraging Diversity)

The salary range for this position is: $172,890.00 - $223,740.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact

careers@gilead.com

for assistance.

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For Current Gilead Employees and Contractors:

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