Associate Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with the Director of Clinical Operations to create and oversee clinical programs that align with corporate goals and timelines.

• Provide operational guidance for the planning, execution, and analysis of clinical trials and data collection.

• Develop and track timelines, budgets, risks, and mitigation strategies for clinical trials and programs.

• Mentor and guide Clinical Trial Managers and junior staff members.

• Supervise daily operations of Clinical Trial Operations and Clinical Data Management teams.

• Work with Finance/Business Operations on budget planning, evaluations, and re-forecasts.

• Design, implement, and oversee strategies for clinical vendor outsourcing.

• Participate in vendor selection processes and governance committees.

• Ensure clinical trials are prepared for inspections and effectively managed by cross-functional Study Execution Teams.

• Act as a subject-matter expert in Clinical Operations on product cross-functional core teams as necessary.

• Collaborate with Quality to uphold inspection readiness.

• Work with Regulatory Affairs and Clinical Sciences on regulatory submissions and compliance needs.

• Address escalated study challenges and formulate risk mitigation plans.

• Coordinate the development and maintenance of clinical SOPs while reviewing cross-functional SOPs and documents.

• Assist in the creation and review of protocols, amendments, study documents, plans, and operational execution.

• Engage in CRO, site, and vendor selection; monitor progress and initiate contingency plans as needed.

• Contribute to the optimization of Clinical Operations processes and procedures and manage clinical resources for effective trial execution.

⛳️ Requirements

• A B.S./B.A. in Life Science or a related field is required.

• An advanced degree (M.S./M.A., MPH, MHS, MBA) is preferred.

• Clinical Research certification is preferred, though not mandatory.

• A B.S./B.A. with at least 9 years of industry experience in clinical development, including a minimum of 3 years in a managerial role, or an M.A./M.S. with 4+ years of experience.

• Experience in Ophthalmology/Retina is mandatory.

• Relevant experience in executing clinical trials across all phases.

• Demonstrated capability to recruit, retain, organize, and motivate clinical operations staff.

• Proficient in communicating updates and priorities to Clinical Operations and Development Leadership while advocating for necessary budgets and resources.

• Capable of managing and overseeing programs with a corporate-wide impact.

• Skilled in developing and managing functional and clinical trial-specific budgets.

• Ability to prioritize and manage a high volume of work with a keen attention to detail.

• Strong interpersonal skills.

• Comprehensive understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials.

• Adaptable and flexible to meet changing business needs.

• Excellent communication and interpersonal abilities.

• Proficient in writing clearly and summarizing information effectively.

• Capable of presenting complex information to diverse audiences.

• Willingness to travel approximately 20%, or as required by trial needs.

• Ability to meet the sedentary work and repetitive motion physical requirements as specified.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment.

• Competitive compensation and performance-based incentives.