Associate Director, Clinical Operations (Contract)

General Summary

The Associate Director, Clinical Operations will be responsible for implementation, execution and oversight of all 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.

Major Duties & Responsibilities

• Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines
• Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans
• Provide guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing
• Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups
• Collaborate with Finance/Business Operations on annual budget planning, quarterly budget reviews and re-forecasts; design, implement and oversee clinical vendor outsourcing strategy; participate in vendor selection and governance
• Ensure that each clinical trial is always inspection ready
• Ensure that each clinical trial is actively managed by a cross-functional Study Execution Team (SET)
• May sit on product cross-functional core teams as Clinical Operations SME
• Partner closely with Quality to ensure programs and 4DMT remain inspection ready
• Collaborate with Regulatory Affairs and Clinical Sciences on creation of regulatory submissions and compliance to regulatory requirements
• Address escalated study issues in collaboration with CTMs and senior management inclusive of risk mitigation plans
• Coordinate development and maintenance of clinical SOPs and provide review/input into cross-functional SOPs
• Support development and review of protocols/amendments, study documents and plans, and operational execution
• Actively participate in CRO, site and vendor selection; provide ongoing surveillance of progress and ensure contingency plans are triggered as appropriate
• Contribute to development of Clinical Operations department processes and procedures and manage clinical resources

Qualifications

Education: 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.

Experience: 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. Require 1+ years ophthalmology trial experience as well as late phase trial experience. Relevant experience in clinical trial execution across all phases.

Other Qualifications/Skills

• Proven ability to recruit, retain, organize, and motivate clinical operations personnel
• Ability to communicate updates and priorities to Clinical Operations and Development Leadership team and 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
• Self-motivating; prioritize and manage a large volume of work; attention to detail
• Strong interpersonal skills essential for partnering with various team members and functional groups
• 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

Travel: Anticipate 20%, or as trial needs demand.