Sr. Manager, Clinical Development

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   

• 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).   

• 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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