The Associate Director, Clinical Operations will be responsible for implementing, executing, and overseeing clinical trials within a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations.
Requirements
- B.S./B.A. in Life Science or related discipline required
- Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred
- Clinical Research certification preferred, but not required
- B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience
- Requires 1+ years ophthalmology trial experience as well as late phase trial experience. Relevant experience in clinical trial execution across all phases
- Proven ability to recruit, retain, organize, and motivate clinical operations personnel
- Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources
- Ability to manage and oversee programs that have corporate-wide impact
- Ability to develop and manage functional and clinical trial-specific budgets
- Must be self-motivating; prioritize and manage a large volume of work; show attention to detail
- Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
- Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
- Ability to be flexible and adaptable to changing business needs
- Excellent communication and interpersonal skills
- Must be able to write clearly and summarize information effectively
- Must be able to present complex information to various audiences
Benefits
- Paid Time Off
- 401k Matching
- Retirement Plan
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
