About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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.
Qualifications
- 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.
Applicable 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.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Skills Required
- Advanced degree (MD, DO, PhD, PharmD, or MA with relevant experience)
- Clinical development experience, typically 7+ years
- Experience developing novel aesthetic medical devices with similar product profiles
- Knowledge of regulatory requirements for clinical trials and experience designing/executing registration-track protocols
- Direct experience interacting with regulatory bodies (US and Global)
- Proven ability to collaborate effectively in cross-functional teams
- Excellent oral and written English communication skills; motivated self-starter
- Experience in international markets
- Based in Irvine, CA with a hybrid schedule (3 days in office)
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
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Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
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Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
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