CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Director Software Engineering - Commercial Banking Cash Mgt
Description: Responsibilities The Director of Software Engineering for commercial cash management and liquidity for will lead an engineering operation that encompasses a wide-range of products and initiatives. The (more...)
Company: Citizens
Location: West Warwick
Posted on: 02/26/2021

Telephonic Nurse Case Management (LPN/LVN #)
Description: Maxim Healthcare Services is searching for Nurse Case Investigators and Case Investigators COVID for long term contract opportunities located on-site in Concord, NH. Investigators are needed to provide (more...)
Company: Maxim Healthcare
Location: Concord
Posted on: 02/26/2021

Director of Sales and Marketing
Description: Sunrise Senior Living is an Equal Opportunity Employer. Director of Sales Assisted Living in Plymouth, Michigan - Careers at Sunrise of Northville MI Skip to Main Content Please Enable Cookies to Continue (more...)
Company: Sunrise Senior Living
Location: Plymouth
Posted on: 02/26/2021


Program Manager
Description: RESPONSIBILITIES:Kforce's East Hartford, CT based client is looking for a Program Manager on a contract basis.Duties: Create and manage long term goals Manage vendor relationships, SOW, and vendor budgets (more...)
Company: Kforce Technology Staffing
Location: East Hartford
Posted on: 02/26/2021

Physician / Hospitalist / Massachusetts / Permanent / Medical Director
Description: Id : 8698Category : PhysicianLocation/City : MA - LawrenceSalary Range : 0.00 - 0.00 per year
Company: Brine Group Staffing Solutions
Location: Lawrence
Posted on: 02/26/2021

Sales and Marketing Manager
Description: Classification: Exempt Type: Full-time Reports to: President Date: February, 2021 Location: Lawrence, MA Title: Sales and Marketing Manager The Manager, Sales and Marketing is responsible for developing (more...)
Company: Silverio Insurance Agency
Location: Lawrence
Posted on: 02/26/2021

Medical Director- Pharmacovigilance - GI
Description: By clicking the -Apply- button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's , and .Job DescriptionAre you looking for a patient-focused (more...)
Company: Biolife Plasma Services
Location: Peabody
Posted on: 02/26/2021

Director, SOE Strategy & Resourcing Lead
Description: United States - Connecticut - Groton Pharmaceutical Sciences Small Molecules PSSM develops the formulations and manufacturing processes needed to transform laboratory candidates into potential new (more...)
Company: Pfizer
Location: Groton
Posted on: 02/26/2021

Real Estate Dispositions Manager
Description: We are a high-performance real estate team on the lookout for a full-time, real estate Disposition Manager. This lucrative position is instrumental in the growth and success of our business, so we provide (more...)
Company: Inherited Property Solutions
Location: Nashua
Posted on: 02/26/2021

Director of Rehab - Clinical (DOR)
Description: FULL TIME POSITION br Genesis Rehab Services is a leading provider of Physical, Occupational, Speech and Respiratory Therapy for older adults in skilled nursing facilities, independent and assisted (more...)
Company: Genesis Rehab Services
Location: Peabody
Posted on: 02/26/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds