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/scientific direction to project/study teams and mentors junior team members.
Location/Schedule: Irvine, CA (hybrid; 3 days in office).
Responsibilities:
- Under the Global Clinical Development Lead, design, direct, execute, and interpret clinical trials/research and data collection in support of the Product Development Plan.
- Collaborate cross-functionally to generate, deliver, report, and interpret high-quality clinical data; monitor protocol adherence and correct endpoint data collection.
- Design Clinical Development Plans (from early translational to mature lifecycle strategies).
- Design, conduct, and report clinical trials aligned to development, regulatory, and commercial strategy.
- Review/interpret/communicate safety and efficacy data; oversee study enrollment and key deliverable timelines with Clinical Operations.
- May lead 0β5 employees; engage external experts/investigators.
- Coordinate scientific activities with medical affairs, commercial, clinical operations, discovery, statistics, regulatory, etc.
- Support scientific education; act as a subject matter expert; represent the company at external meetings.
- Ensure compliance with regulatory requirements; coordinate/develop information for FDA and Global Regulatory Authorities reports.
- May initiate research projects leading to high-quality publications.
- Lead cross-functional sub-teams and ensure scientific validity, integrity, and quality of Clinical Development Plan content (protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, publications).
- Ensure 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 7+ years); novel aesthetics medical device development experience desirable.
- Knowledge of clinical trial regulatory requirements; experience with registration-track protocols leading to regulatory submission expected.
- Direct regulatory body experience (US and Global) highly advantageous.
- Proven cross-functional collaboration; excellent English communication; self-starter.
- International market experience highly desirable.