Job DescriptionThe Associate Director, Clinical Development will have regional and/or global responsibilities. Leads the design, development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data from a clinical development program. Provides medical and/or scientific direction to project/study teams. 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 will be based in Irvine, CA with a hybrid schedule of 3 days in office.
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.
Under the appropriate supervision:
- 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.
QualificationsQualifications
- Advanced education (e.g., MD, DO, PhD, PharmD, or MA with relevant experience) preferred.
- Clinical Development experience is required, typically 7+ 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.
- Experience in international markets is highly desirable.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
