The 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. Provides medical and/or scientific direction to project/study teams, mentors junior team members, and may participate in internal process improvement activities.
Responsibilities:
- Under supervision, designs, directs, executes, and interprets clinical trials/research and data collection activities in support of the Product Development Plan.
- Collaborates with cross-functional teams to generate, deliver, report, and interpret high-quality clinical data; monitors protocol adherence and endpoint data collection.
- Designs Clinical Development Plans (may span early translational through mature life cycle strategies).
- Designs, conducts, and reports clinical trials in line with development, regulatory and commercial strategy.
- Reviews, interprets, and communicates accumulating safety and efficacy data.
- With Clinical Operations, may oversee study enrollment and timelines for key deliverables.
- May lead 0β5 employees in a matrixed environment.
- May engage external experts and investigators.
- Coordinates scientific activities with internal stakeholders (medical affairs, commercial, clinical operations, discovery, statistics, regulatory, etc.).
- Assists in scientific education of investigators, clinical monitors, and Global Project Team members.
- Stays current via conferences/literature; acts as subject matter expert.
- Represents AbbVie at external meetings.
- Ensures compliance with regulatory requirements related to clinical studies.
- May coordinate/develop information for FDA and Global Regulatory Authority reports.
- May initiate research projects aligned with project goals, resulting in high-quality publications.
- Leads cross-functional sub-teams for defined sub-projects.
- Accountable for scientific validity, integrity, and quality of the Clinical Development Plan and all clinical content (protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, publications).
- Leads scientific/clinical execution of the Clinical Development Plan and serves as key contact for scientific/clinical aspects.
- Ensures review of clinical data, including protocol deviations.
Qualifications:
- Advanced education preferred (MD, DO, PhD, PharmD, or MA with relevant experience).
- Clinical Development experience required, typically 5+ years; successful development of novel medical devices in Aesthetics with similar product profiles is very desirable.
- Knowledge of clinical trial regulatory requirements; experience designing and executing registration-track protocols leading to regulatory submission is expected.
- Direct experience with US and global regulatory bodies is highly advantageous.
- Proven cross-functional collaboration ability.
- Excellent oral and written English communication; motivated self-starter.
- International markets experience highly desirable.
Benefits (if explicitly stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible to participate in short-term incentive programs.
Application instructions:
- Not specified in the job description text provided.