Director I Clinical Development
Director I Clinical Development
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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 crossfunctional teams to generate deliver report and interpret highquality 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 of human clinical trials from early translational efforts to postmarket research and noninterventional 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 05 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 ongoing 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 subteams responsible for defined subprojects 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 of registrationtrack 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 crossfunctional setting.
- Excellent oral and written English communication skills and demonstrable evidence of being a motivated and successful selfstarter.
- 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 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
