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About Allergan Aesthetics

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

Clinical Development Lead - CoolSculpting

Pleasanton, California Req ID 2208547 Category Research and Development Division Allergan Aesthetics

The Clinical Development Lead is responsible for providing scientific and clinical development direction and guidance at the product, project, and study level.  S/he will lead, guide, and mentor a staff in the respective Therapeutic Area, to drive scientific innovation on clinical proposals, and develop leaders for the future. Several roles can be fulfilled by the incumbent for the specific Therapeutic Area:

As the Clinical Lead, s/he is 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.

The Clinical Development Lead may also perform the role of Global Development Lead, (dependent on asset positioning within Asset Strategy Team) where s/he is responsible for the leadership of a cross-functional global project development team on one or more projects.

As the Clinical Scientist, s/he has responsibility for providing scientific and clinical development guidance at the global product, project and study level. 

S/he will represent R&D at regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Device industry. 

The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.  Other activities, special projects and assignments may be given as necessary.  As a result the percentage of time spent across the roles for which the employee is responsible or accountable will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

The employee must conduct his/her work activities in compliance with all relevant regulations, ISO, GCP, ICH, PhRMA, and CFR guidelines as well as all AbbVie policies, and procedures.  AbbVie policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Key Duties and Responsibilities:

Clinical Lead

The incumbent is responsible for the leadership and the results of the clinical team throughout the Global Clinical Development process. The Clinical Lead represents the clinical team in the integrated evidence strategy team (IEST).

The incumbent has overall responsibility for ensuring the development and execution of the clinical strategy.  This includes responsibility for the clinical team’s creation of relevant documents and outputs  including Clinical Development Plan (CDP), clinical program feasibility, Investigator’s brochure, study protocol synopsis, clinical study protocols, top line study data communication plan, Clinical Study Report (CSR), clinical sections of regulatory documents including the clinical sections of the CTD for regulatory submissions, and planning of the Annual reports together with Regulatory affairs and respective clinical team members. S/he ensures alignment of the CDP with the Global Development Plan (GDP).  In addition, working collaboratively with the Program Operations Lead, the Clinical Lead oversees achievement of all activities related to the Clinical development program, including achievement of key program milestones within the planned time lines and budget.  The Clinical Lead is accountable to the Clinical Development TA Head for the Clinical Development budget.

In addition, the incumbent is the key contact for relationships to external experts/ Key opinion leaders and provides regular scientific and clinical trial updates, etc.

General Compliance and Other Role(s)

The incumbent is responsible for adherence to all relevant regulations e.g.: ICH, PhRMA and CFR guidelines, as well as AbbVie’s policies, SOPs and Work Instructions.  Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.  Provide strategic and/or technical consultations on behalf of the therapeutic area (e.g., study design, business development, marketing, communications, training, legal, etc.).

 


  • MD, PhD or PharmD preferred
  • Therapeutic Area experience strongly preferred
  • 10+ years relevant clinical/drug development experience including experience working in clinical research with a strong understanding of the clinical and global drug development process
  • 5+ years’ experience as a cross-functional team leader preferred
  • Ability to travel up to 30% of time
Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
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