Associate Director, Clinical Operations (Retina Program)

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
• Guides and mentors 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
• Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.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

• 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 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
• 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
• Physical Requirements And Working Conditions: Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).