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Senior Manager Clinical Development

Company: Analytic Search Group
Location: Irvine
Posted on: February 23, 2021

Job Description:

Sr. Manager, Clinical Development (Devices)

  • --California, United States
  • --Research & Development
  • --202900Job DescriptionEnvision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.What Your New Manager Wants You To Know--The Sr. Manager, Clinical Development (Devices-Aesthetics of Global leader in well known products) will have global or regional responsibilities and fulfil the roles of Clinical Program Lead, Clinical Science Lead and Clinical Scientist.
    The Sr. Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.
    --
    YOU ARE more than just a title, YOU ARE---First class team player:--collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.--You Will--
  • As the--Clinical Program Lead, be responsible and accountable for the development, implementation and delivery of the global clinical development strategy for a given project within time, budget and with high quality. This will entail leading the development of the Clinical Development Plan in collaboration with the Clinical Science Lead and members of the Clinical Sub-Team and ensuring alignment with the agreed Global Development Strategy. Once completed, the CPL leads the execution of the agreed Clinical Development Plan and is responsible for:
    • Ensuring alignment between the Core Team, Clinical Sub-team and Clinical Trial Team(s)
    • Developing the proposed clinical milestones with the Clinical Sub-team
    • Working towards the achievement of defined project stage gates and milestones
    • Overseeing all clinical development activities in collaboration with the Clinical Sub-Team and Clinical Trial Team(s)
    • Managing the project-related clinical development budget with the Clinical Sub-Team and Project Manager
    • Ensuring that decisions made by the Clinical Sub-team have functional backing
    • Communicating project progress to their line function managers
    • Communicating to the Core Team leader, Core Team and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) upon identification in a timely manner
    • Providing Clinical Development oversight on clinical development aspects for ongoing clinical trials
    • As--the--Clinical Science Lead, be responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications associated with the clinical trials.
      You will participate in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, the CSL is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan and is responsible for:
      • Acting as a key contact for the Core Team, Clinical Sub-team and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project.
      • Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members.
      • Ensuring the review of clinical data, including protocol deviations.
      • Interpreting and communicating, with the CPL, clinical trial results.
      • Collaborating with the CPL, the Clinical Sub-team and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications).
      • As the--Clinical Scientist, be responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The position supports the Clinical Project Lead and Clinical Science Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications)
        by contributing to scientific/clinical information aligned with the strategy. The position is the key Clinical Development contact for the Clinical Trial Team and is responsible for:
        • Representing Clinical Development as a core team member on the Clinical Trial Team.
        • Providing a clinical review of study-specific documentation and training materials. Writing of clinical study reports and specifically the clinical portions of regulatory submissions
        • Performing clinical data reviews
        • Assessing reported protocol deviations
        • Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team.#LI-PD1

          Qualifications

          You Bring
          • Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Devices)--preferred.
          • Minimum 5 years of overall work experience or equivalent combination of experience and education.
          • Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred.
          • Ability to travel up to at least 30% of time, including international travelIn this role, we're looking for a leader who will:
            • Act as an Owner
            • Be Excellence Focused
            • Act as an Influencer

              Travel
              Yes, 25 % of the Time

              Job Type
              Standard

              Schedule
              Full-time

              Apply Preferred Member of the TopEchelon Network, a professional group of over 600 partner firms providing direct hire and contract staffing nationwide.

Keywords: Analytic Search Group, Irvine , Senior Manager Clinical Development, Executive , Irvine, California

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