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Allergan Aesthetics, an AbbVie Company · 3 days ago

Associate Director, Aesthetics Clinical Development

Irvine, CA

Full-time

Hybrid

Lead/Staff, Director/Executive

$138K/yr - $261K/yr

5+ years exp

AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines. The Associate Director, Clinical Development will lead the design, development, and execution of clinical studies while ensuring the scientific integrity of study data and providing direction to project teams.

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Responsibilities

Under supervision of the Global Clinical Development Lead, designs, directs, executes, and interprets clinical trials/research and data collection activities in support of the overall Product Development Plan, within time, budget, and based on strong scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues

Collaborates with cross-functional teams to generate, deliver, report, and interpret high-quality clinical data supporting overall product scientific and business strategy, including monitoring adherence to protocols and ensuring correct endpoint data collection

Designs Clinical Development Plans. Responsibilities may extend from early translational development activities to mature product life cycle strategies

Designs, conducts, and reports clinical trials in line with the development, regulatory and commercial strategy

Has responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the asset

Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables

May lead 0-5 employees in a matrixed environment

May be responsible for external expert and investigator engagement within the therapeutic area

Interacts with and co-ordinates appropriate scientific activities with internal stakeholders (i.e. medical affairs, commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to planned and on-going clinical studies or projects

Assists in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area

Keeps abreast of professional information and technology through conferences or medical literature and acts as a subject matter expert

Represents AbbVie at external meetings including investigator meetings, scientific association meetings, partner discussions, etc

Responsible for understanding the regulatory requirements related to clinical studies and accountable for complying with those requirements

May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities

May initiate research projects compatible with project plan goals and drive them to completion, resulting in high quality publications

Leads cross functional sub-teams overseeing defined sub-projects within the therapeutic area

Responsible and accountable for the scientific validity, integrity and overall quality 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

Participates in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, in collaboration with Clinical Operations, is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan, acting as a key contact for the Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project

Ensures the review of clinical data, including protocol deviations

Qualification

Clinical DevelopmentRegulatory RequirementsMedical Device DevelopmentOralCross-functional CollaborationWritten CommunicationInternational Market ExperienceMentoringSelf-starter

Required

Advanced education (e.g., MD, DO, PhD, PharmD, or MA with relevant experience) preferred

Clinical Development experience is required, typically 5+ years

Experience in the successful development of novel medical devices in Aesthetics with similar product profiles as those in development by AbbVie, is very desirable

Knowledge of regulatory requirements governing clinical trials, along with experience in the design and successful execution of registration-track protocols leading to regulatory submission is expected

Direct experience with regulatory bodies (US and Global) is highly advantageous

Proven ability to collaborate effectively in a cross-functional setting

Excellent oral and written English communication skills and demonstrable evidence of being a motivated and successful self-starter