Executive Director, ClinOps Oncology Franchise Head

Company: Gilead Sciences
Location: Boston
Posted on: August 7, 2022

Job Description:

Gilead has a rich pipeline of promising medicines across multiple indications in Oncology with numerous submissions and readouts planned through 2025. -There are > 10 active pivotal registrational trials, a robust early-mid phase pipeline, and a myriad of partnerships, collaborations, and opt-ins that require executive leadership and oversight. - Oncology is a highly competitive landscape and flawless execution will be paramount to success. To ensure Gilead is positioned for success, the ClinOps Oncology Team will establish Disease Area Franchise Heads to develop the ClinOps disease area strategy and partner closely with the corresponding Franchise Heads within Clinical Development, Regulatory, and other key functions to deliver the disease area portfolio.The ClinOps Oncology Franchise Head 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) with global scope and accountability across multiple GDTs and SMTs. In addition to setting the ClinOps 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. Individuals in this role will be accountable for delivery in their respective therapy area and must have a proven track record to manage performance both internally and with external suppliers. The ClinOps Oncology Franchise Heads will be standing members of the Oncology Clinical Operations Leadership Team and will exhibit enterprise leadership by positioning the broader group for success and optimizing processes to enable top quartile performance. Leaders will exhibit an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations. The ClinOps Oncology Franchise Head (Executive Director), will report into the Vice President of Clinical Operations, Oncology.EXAMPLE RESPONSIBILITIES:

• Will lead a large team (approx. 50 people) and serve as the single point of accountability for establishing the ClinOps Oncology Disease Area Strategy to enable delivery to planned/accelerated timelines
• Accountability across multiple GDTs and several assets to set delivery strategy that considers both internal/external competitive landscape, standard of care, accessibility and reimbursement, partnership opportunities, to ensure Gilead is positioned to "win" in Oncology
• Partners closely with corresponding Franchise Heads in 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, biomarkers, 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.REQUIREMENTS:We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
  • BA / BS / RN with 16 or more years' relevant clinical or related experience in life sciences. -Or, MA / MS / PharmD / PhD with 14 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.Knowledge & Other Requirements
    • 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 Harmonization 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.

Keywords: Gilead Sciences, Boston , Executive Director, ClinOps Oncology Franchise Head, Executive , Boston, Massachusetts