Director I, Clinical Development

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

Location: Onsite hybrid schedule in Irvine, CA or Pleasanton, CA

Under supervision of the Clinical Lead, designs, directs, executes, and interprets clinical trials/research and data collection activities in support of the overall Product Development Plan, based on strong scientific principles, knowledge of compliance and regulatory requirements, AbbVies 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.

Responsibilities may also include directing the execution of human clinical trials, from early translational efforts to post-market research, and non-interventional studies.

Responsibilities

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 opinion leader development and investigator recruitment within the therapeutic area.
• Interacts with and coordinates 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 therapeutic area resource.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, partner discussions, etc.
• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
• May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities.
• Leads cross functional sub-teams responsible for defined sub-projects within the therapeutic area.
  
  
  

Qualifications

Expected Education and Experience:

• Advanced education (e.g., MD, DO, PhD, PharmD, or MBA with relevant experience) preferred.
• Clinical trial development experience is required; typically, 8 years experience in clinical trials or equivalent; Clinical operations experience is preferred.
• Experience with successful development of novel medical devices and involvement in Aesthetics programs with similar product profiles as those in development by AbbVie is very desirable.
• Knowledge of regulatory requirements governing clinical trials and experience in the design and successful execution of registration-track protocols leading to regulatory submission highly favored. May have performed protocol design in the academic environment and/or acted as an assistant Principal Investigator or Principal Investigator.
• Direct experience with regulatory bodies (FDA and Global regulatory agencies) is highly advantageous.
• Ability to influence and gain cooperation from others, conduct presentations of technical information concerning specific projects/schedules, etc. Ability to interact externally and internally to support global strategy.
• Ability to demonstrate strong experience of collaboration 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 a plus.
  
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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 protected veteran, or any other legally protected group status.

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