Hourly Wage for ABBVIE INC Associate Director, Clinical Development - Aesthetics Salary in the United States

The Associate Director, Clinical Development will have global or regional responsibilities and fulfil the roles of Integrated Evidence Strategy Team (IEST) lead, Clinical Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director, 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.

The position may be remote based in U.S.

Responsibilities:

• Ensuring alignment between the Governance Board, IEST and deliverable Sub-teams

• Developing the project milestones with the IEST and seeking endorsement from the Governance Board on the Global Development Strategy, Stage Gates and other decisions requiring Governance Board endorsement

• Guiding the project through the defined Stage Gates

• Analyzing, managing project risks and proposing solutions for risk mitigation

• Resolving project/functional conflicts

• Managing, together with the Project Manager, the project budget and timelines

• With the Project Manager and core project team members from Commercial, managing the valuation of the project

• Communicating any potential risks to the Governance Board co-chairs and any relevant line functions in a timely manner

• If applicable, managing external partnerships and ensuring alignment and preparation for Joint Development Committee (JDC) meetings

• Ensuring alignment between the IEST, and Clinical Trial Team(s)

• Developing the proposed clinical milestones with the Clinical Trial team

• Working towards the achievement of defined project stage gates and milestones

• Overseeing all clinical development activities in collaboration with the IEST and Clinical

• Trial Team(s)

• Managing the project-related clinical development budget with the Clinical Trial Team and Project Manager

• Ensuring that decisions made by the Clinical trial team have functional backing Communicating project progress to their line function managers.

• Communicating to the IEST Lead, IEST 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 IEST, 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, 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.