Associate Director, Clinical Operations

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 effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans
• Provides 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 (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees
• Ensure that each clinical trial is always inspection ready
• Ensure that each clinical trial is being 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 that the programs and 4DMT always remain inspection ready
• Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (e.g., Clinicaltrials.gov)
• Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans
• Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/input into cross-functional SOPs and other documents
• Supports development and review of protocols/amendments, study documents and plans, and operational execution
• Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
• Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials

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. Ophthalmology/Retina experience required. Relevant experience in clinical trial execution across all phases.

Skills & Other Requirements

• 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

Pay

Base salary compensation range: $179,000 - $205,000. The actual salary offered depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.

Schedule & Travel

• Travel: Anticipate 20%, or as trial needs demand
• Physical Activity: Repetitive motions (wrist, hands, and/or fingers); fingering (picking, pinching, typing); talking (expressing or exchanging ideas by means of the spoken word)
• Physical Requirements: Sedentary work (exerting up to 10 pounds of force occasionally; sitting most of the time; walking and standing only occasionally)
• Working Conditions: Not substantially exposed to adverse environmental conditions (typical office or administrative work)