VICE PRESIDENT, HEAD OF GLOBAL DEVELOPMENT OPERATIONS
Company: Patelco Credit Union
Posted on: February 16, 2021
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
- 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,
- 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
- 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
- Extensive experience as a hiring manager with a proven track
record for attracting talent, building and maintaining strong
- 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
- 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
- Proven ability to work and lead effectively in a highly
collaborative team environment with an emphasis on
- Strong relationship management and leadership skills; strong
ability to collaborate with the executive and management
- 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
- 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
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