What are the responsibilities and job description for the Director I, Clinical Development position at Allergan Aesthetics, an AbbVie Company?
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, 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.
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.
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, 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.
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.
