Executive Director Global Clinical Supply Chain - Oncology
Executive Director Global Clinical Supply Chain - Oncology
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$ 281010 - 363660
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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
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 lifethreatening diseases including HIV viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide with headquarters in Foster City California.
Executive Director Global Clinical Supply Chain (GCSC)
KEY RESPONSIBILITIES:
Executive Director Global Clinical Supply Chain is responsible for leading clinical planning function within an assigned therapeutic area (TA). The incumbent is an endtoend leader who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on a diverse portfolio of development programs and different therapeutic modalities including small molecules biologics and cell gene therapy for Gileads global clinical trials.
The Executive Director works internally with members in GCSC and other functions including and are not limited to Development Operations Clinical Operations and Process Development and Manufacturing (PDM) to develop strategies meet project deliverables solve business problems and create competitive advantage. This position includes endtoend elements of clinical planning and from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.
FOCUS AREA:
- Establishes strategies to ensure uninterrupted clinical supply for the overall development portfolio including clinical development programs and studies at all phases as well as managed access programs. May lead large complex projects within department and represent GCSC in crossfunctional projects.
- Leads develops and manages team which includes and not limited to recruitment onboarding and succession planning.
- Drives excellence and accountable for setting clear goals and consistently delivering. Accountable for setting team goals in alignment with department and enterprise goals
- Responsible for developing and maintaining a culture of continuous improvement. Mobilizes teams to develop plans works cross functionally within PDM and at the enterprise level to identify and implement best practices.
- Performs sponsor roles as requested.
- Champions clinical demand and operation planning (CD&OP) interfacing with leaders from Clinical Operations PDM subteams. Manages across enterprise functions and partners to ensure on time in full delivery of investigational medicinal product (IMP).
- Ensures efficient and robust resource allocation for PDM subteams and clinical study teams.
- Partners across several PDM functions and with other enterprise functions to ensure the on time in full (OTIF) delivery of IMP to initiate and resupply clinical studies.
- Responsible for decisionmaking and direct the longterm vision of optimal supply chain strategies including labeling and distribution activities.
- Responsible for risk balancing by allocating work. Identifies and champions areas where process improvements are imperative. Drives resolution of complex issues through partner sponsors as needed.
- Responsible for planning SOPs Work Instructions business policies and procedures to ensure GxP compliance. Influence crossfunctional SOP content and review/approve as required.
- Oversees and supports clinical study planners. Facilitates issue and risk identification mitigation resolution and communication.
- Serves as the PDM subteam for RFD assets lead supply management for first in human (FIH) clinical trials.
- Drives decisionmaking at crossfunctional teams (ClinOps PDM subteams) supporting the longterm vision.
- Responsible for the departmental budgeting process forecasts clinical supply spends estimates headcount requirements as well as department related expenses (contractors consultants recruitment project expenses etc..
- Leads TA level allocations decisions and influences and negotiate partner performance.
Basic Qualifications:
- 16 Years of relevant industry experience with BA/BS. OR 14 Years with MA/MS or MBA PHD or PharmD.
- Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment.
- Has strong crossfunctional multicultural awareness and communication skills to lead in a fastpaced global company.
- The candidate must demonstrate handson endtoend clinical supply knowledge and experience with clinical trials in therapeutic area of oncology while maintaining elevated strategic oversight at portfolio level.
Preferred Skills:
- Degree in a sciencerelated field; MS PharmD or MBA desirable.
- 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.
- Prior experience in complex Oncology trials is highlypreferred.
- Proven strong and effective collaboration influencing and negotiation skills to work successfully with internal crossfunctional 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 and other comeds 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 facetoface and with appropriate responses.
- Expert in leading through ambiguity can assess options quickly and efficiently implement the best option in alignment with Gileads 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 lead or manage TA department level and crossfunctional projects.
Gilead Core Values
Integrity (Doing Whats Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Required Experience:
Exec
Employment Type
Full-Time
