- Will lead a large team (approx people) and serve as the single point of accountability for establishing the ClinOps Oncology Disease Area Strategy and to enable delivery to planned/accelerated timelines
- Accountable for portfolio delivery across multiple GDTs and several assets that considers both interna/external competitive landscape, standard of care, accessibility and reimbursement, partnership opportunities, to ensure Gilead is positioned to "win" in Oncology
- Leadership on joint working groups and steering committees with partner companies (e.g. Arcus Biosciences)
- Partners closely with corresponding Franchise Heads in Clinical Development, Regulatory, Med Affairs, Project Mgmt, and other key functions to contribute to development plans, DRC presentations, and strategy for scientific conferences/engagement
- Will be a standing member of the Oncology Clinical Operations Leadership Team and will contribute to the broader Oncology ClinOps Business Plan
- Creates the ClinOps Oncology disease area strategy and roadmap to ensure Gilead is positioned to deliver flawlessly on its pipeline objectives. Has deep understanding of disease area, biormakers, adaptive trial designs, etc and a proven track record of employing creative solutions to drive acceleration of the portfolio
- Serves as a talent magnet and will develop, coach, and retain top diverse top talent in the team. Sets clear, stretch goals for the team and individual direct reports. Coaches team on their performance, development and career interests
- Will drive top quartile performance via implementation of novel partnerships, site networks/cooperative groups/consortia
- Partners closely with the corresponding Franchise Heads in Clinical Development, Regulatory, and other key functions to develop the disease strategy and to share progress against the therapy area deliverables.
- Experience leading organizations through change to optimize performance and understanding of how to bring the broader team on the journey
- Accountable for successful strategies, oversight, and completion of a broad spectrum of clinical operations activities and deliverables for a large portfolio of products, compounds, indications and/or other projects in the assigned therapeutic area
- Able to forge strong partnerships and provide oversight for the contract research organizations (CROs) and other resources
- Leads and partners in the development and presentation of the clinical operations' strategy to executive leadership
- Collaborates with various cross-functional groups to define, oversee and contribute to ongoing lifecycle management of all therapeutic area products
- Partners with key stakeholders to solve organizational challenges/issues
- Maintains financial oversight of the assigned group; managing spend as planned and ensuring appropriate communication with other groups
- Identifies, assigns and oversees development of clinical operations' change and organizational excellence initiatives, including best practices, knowledge management, standardization and SOPs
- Partners closely with key stakeholders to ensure ClinOps Oncology is positioned to delivery near term regulatory submissions
- May function as the executive sponsor for oncology preferred vendor relationships
- Collaborates cross-functionally on due-diligence efforts and assessments for mergers and acquisitions
- Ensures team's work complies with established practices, policies and processes, and any regulatory or other requirements
- Champions and role models Gilead Core Values and Leadership Commitments with an appropriate balance of Portfolio Delivery, People Management, and Organizational Excellence/Innovation
- BA / BS / RN with 14 or more years' relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 12 or more years' relevant clinical or related experience in life sciences.
- Extensive experience leading high-complexity cross-functional initiatives in life sciences, including short- and long-range strategic planning, governance, team management and oversight.
- Experience in oncology and track record of establishing key partnerships/alliances within oncology
- Extensive line management experience. Typically has multiple years' experience managing other people leaders (with indirect reports). Experience managing teams of > 30-50 people
- Experience on governance committees and management teams for CROs or other vendors.
- Demonstrated excellence leading large and complex teams in life sciences.
- Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources.
- Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.
- Expert knowledge of pharma and/or biopharma industry, including in-depth understanding of other business functions, as evidenced by proven track record of leading organizations and teams to achieve short- and long-range strategies, plans and objectives
- Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials
- Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools
- Proven ability to influence up, down and across the organization and externally in a collaborative manner
- Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
- Exceptional interpersonal skills and understanding of team dynamics
- Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives
- Strong negotiation and conflict resolution skills
- Advanced coaching capabilities to mentor/develop staff
- Strong track record in effectively conceiving and leading large-scale, complex change initiatives
- When needed, ability to travel The salary range for this position is: $216, $279, 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*.
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Gilead Sciences, Inc. Foster City, United States Full timeSr. Clinical Trials Manager, Clinical Operations- Oncology · United States - California - Foster CityUnited States - Washington - Seattle · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in are ...
Senior Director, Clinical Operations - Foster City, United States - Gilead Sciences, Inc.
Description
Description
The Clinical Operations Oncology Franchise Head reports into the Vice President, Oncology Clinical Operations and is a critical leadership role accountable for management of a large group of Clinical Operations professionals ( ͂ 50 FTEs) and people leaders across a disease area (e.g. Hematology, Lung/GI, Breast/Gyn/GU, Early). The leader will have global scope and accountability across multiple GDTs and SMTs. In addition to setting the Clinical Operations disease area strategy, this role will be accountable for establishing strategic partnerships, developing a TA specific business plan, and employing creative operational solutions to position Gilead as the ClinOps industry leader in a disease area.
Key Responsibilities:
Minimum Qualifications:
Knowledge & Other Requirements
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
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 for assistance.
Senior Director, Clinical Operations professionals in Foster City
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vijay yelanji
Manager, Architect, Tech Lead and Developer