At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Senior Director, Global Clinical Supply Chain is an end-to-end clinical supply planning leader that provides relevant expertise in a fast-paced biopharmaceutical environment. The Senior Director works internally with other members of Global Supply Chain (GSC) and other Gilead functions - e.g., Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory, and Project Management Office - to develop and formulate supply chain strategies, meet project deliverables, solve business problems and create competitive advantage.
This position includes all elements of the clinical supply planning from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.
Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.
FOCUS AREA:
Serves as the supply chain lead on PDM product strategy teams especially for complex development programs - e.g., late phase, acquisition, partnership/alliance, new modality, etc.).
Leads the development and execution of overall clinical supply strategy and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials.
Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
Identifies, manages and mitigates supply risks at clinical development program level. Leads and drives visible, impactful process improvements, change business and organizational imperatives.
Authors, revises and reviews standard operating procedures (SOPs), work instructions and business policies.
Accountable for clinical supply budget of assigned clinical development program(s).
Reviews and approves statement of work, purchase orders and invoices.
Influences, at times drives, program allocations at partners, contract manufacturing organizations (CMOs).
Lead or a contributing member to GCSC, GSC or PDM strategic initiatives including and not limited to due diligence resource pool, global drug delivery community, clinical supply integration due to M&A and policy topic member supporting the External Advocacy Steering Team (EAST).
Knowledge:
Able to develop complex concepts, techniques, and standards.
Able to develop solutions to complex problems which require an in depth degree of ingenuity, creativity and innovativeness.
Challenges are frequently unique and solutions may serve as precedent for future decisions, which affect the entire organization.
Recommends organizational objectives and interprets company policies. Must have in-depth expertise in EU and international cGMPs.
Able to interpret, execute, and recommend modifications to department policies.
Demonstrates effective communication skills and the ability to deal across several multi-national agencies, sites and organizations.
Minimum Education & Experience Requirements:
14+ years of relevant experience in related field and a BS or BA; OR 12+ years of relevant experience and a MA/MBA OR 8+ Years with PhD or PharmD.
Requires a bachelor's degree and highly preferable in a science-related field; MS, PharmD, or MBA desirable.
Prior experience in complex, oncology trials is highly-preferred.
Strong clinical supply 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
Proven 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. Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders.
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 GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses.
Expert in leading 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.
Ability to effectively manage resources and timelines for multiple teams with studies of different complexities. Ability to manage departmental and cross-functional projects.
The salary range for this position is: $221,000.00 - $286,000.00. 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.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
