VICE PRESIDENT, HEAD OF GLOBAL DEVELOPMENT OPERATIONS

Company: Patelco Credit Union
Location: Cambridge
Posted on: February 16, 2021

Job Description:

VICE PRESIDENT, HEAD OF GLOBAL DEVELOPMENT OPERATIONS Clinical Development Emeryville, CA Cambridge, MA Description Gritstone Oncology is a fast-growing, innovative biotechnology company developing the next generation of personalized cancer immunotherapies. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors, and very deep financial backing to tackle fundamental challenges at the intersection of cancer biology, immunology and immunotherapy design. The goal is to develop breakthrough immunotherapy treatments for patients with cancer by identifying and deploying neoantigens from each patient's tumor to develop personalized cancer vaccines. Gritstone Oncology is headquartered in the San Francisco Bay Area with certain key functions located in Pleasanton, CA and Cambridge, MA.

The Head of Global Development Operations will be responsible for leading and integrating key operational functions within Development and will participate in the development and implementation of clinical strategies in collaboration with other group/functional leaders in Clinical Development, Clinical Operations, Portfolio Strategy & Operations, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Research, Finance, Legal and HR. This position reports into the Chief Medical Officer.

• Lead and integrate Clinical Operations, Translational Medicine Operations, Statistics, Data Management, Medical Writing and Project Management groups across Gritstone's Development function with accountability for allocating resources, development, mentoring, management and training of a high performing team.
• Act as primary Development Operations interface with group leaders across Development and the rest of the organization to optimize planning efforts and communication.
• Based on deep experience, provide strategic and operational leadership on the direction, planning, execution and interpretation of clinical trials at all stages.
• Build a powerful capability for planning and modeling clinical trial timelines, enrollment assumptions, costs and generating feasibility data; establish best practices for defining, tracking and responding in real time to clinical trial metrics for optimized operational performance and efficiency.
• Develop a strategic and consistent approach for the selection and management of clinical study sites and external vendors (CROs) that support the clinical programs.
• Oversee all data management activities including case report form design, data tracking and generation; successfully manage multiple data read-outs for open label and blinded studies.
• Partner with leadership of internal functions including Research and Translational Medicine to ensure optimization of clinical trial biomarker sample management and operations to meet key and frequent data deliverables across portfolio.
• Collaborate with Regulatory Affairs to support regulatory strategy and delivery of written content and data for submissions; ensure alignment of data output activities of the Medical Writing group to enable the timely and high-quality completion of Clinical Study Reports, Investigator's Brochures, Integrated Summaries, etc.
• Collaborate with HR and Finance teams to assess, plan and manage human and financial resources consistent with the corporate operating plan and ensure support.
• Partner closely with Legal team to ensure that vendor and clinical site contract review processes and workflow are optimally managed.
• Ensure that appropriate capabilities, infrastructure, systems, standards and processes are in place to support execution of Development activities. Qualifications Required
  
  • 12+ years of related experience with 5 years in leadership roles in the biopharmaceutical or biotech industry.
  • Minimum of a B.S./B.A. degree in a relevant scientific discipline
  • Extensive experience as a hiring manager with a proven track record for attracting talent, building and maintaining strong teams.
  • Experience managing early- and late-phase clinical studies is required; proven track record of execution and oversight of successful clinical studies (delivered on time, within budget, and with high quality).
  • Extensive expertise in developing operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality and legal aspects).
  • Strong therapeutic area knowledge and the ability to support the design and execution of clinical programs, preferably in the oncology and/or infectious disease areas.
  • Extensive familiarity with all aspects of clinical Data Management requirements, including a working knowledge of related Biostatistics and Programming principles.
  • Experience managing relationships with external medical and scientific organizations.
  • Proven ability to work and lead effectively in a highly collaborative team environment with an emphasis on problem-solving.
  • Strong relationship management and leadership skills; strong ability to collaborate with the executive and management teams.
  • Proven track record of experience working with contract resource organizations, functional service providers and third-party vendors; strong contract negotiation abilities and thorough understanding of all financial aspects of contracts.
  • Highly effective communicator with excellent writing and presentation skills.
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Willingness to "roll up sleeves" in a start-up environment
  • A strong commitment to the organization's mission You have been redirected to a Gritstone Oncology job page

Keywords: Patelco Credit Union, Cambridge , VICE PRESIDENT, HEAD OF GLOBAL DEVELOPMENT OPERATIONS, Executive , Cambridge, Massachusetts