AbbVie

Sr. Manager, Clinical Development

Employer
AbbVie
Location
Madison, New Jersey
Posted
May 09, 2022
Ref
2200058
Required Education
Bachelors Degree
Position Type
Full time

The Sr. Manager, Clinical Development (Aesthetics) will have global or regional responsibilities and fulfil the roles of Medical or Scientific Director, 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.

Responsibilities: 

  1. As the Medical or Scientific Director, 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/Integrated Evidence Team and ensuring alignment with the agreed Global Development Strategy.  Once completed, the Medical or Scientific Director leads the execution of the agreed Clinical Development Plan and is responsible for:
  • Ensuring alignment between the Clinical Sub-Team/Integrated Evidence Team and Clinical Study Teams
  • Developing the proposed clinical milestones with the Clinical Sub-team/Integrated Evidence Team
  • Working towards the achievement of defined project stage gates and milestones
  • Overseeing all clinical development activities in collaboration with the Clinical Sub-Team/ Integrated Evidence Team and Clinical StudyTeam(s)
  • Managing the project-related clinical development budget with the Clinical Sub-Team/ Integrated Evidence Team and Project Manager
  • Ensuring that decisions made by the Clinical Sub-team/ Integrated Evidence Team have functional backing
  • Communicating project progress to their line function managers
  • Communicating to the Global Development Lead, Integrated Evidence 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 Clinical Sub-team /Integrated Evidence Team and Study 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/ Integrated Evidence Team members.
    • Ensuring the review of clinical data, including protocol deviations.
    • Interpreting and communicating, with the Medical or Scientific Director, clinical trial results.
    • Collaborating with the Medical or Scientific Director, the Clinical Sub-team/ Integrated Evidence 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 Study 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 Study Team and is responsible for:
    • Representing Clinical Development as an Integrated Evidence Team member on the Clinical Study 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 Study Team.

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