Associate Director, Clinical Operations

Position Summary:

The Associate Director, of 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 in order to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations.

Essential Duties & Responsibilities:

• Partner with Sr. 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 (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.

Core Competencies, Knowledge and Skill 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

• Relevant experience in clinical trial execution across all phases

Communication & Interpersonal Skills:

• 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

Requirements:

• BS/BA in Life Science or related discipline; advanced degree (MS, MPH, MHS, Ph.D., MBA) preferred.

• Require 1+ years of ophthalmology trial experience as well as late-phase trial experience.

• A minimum of 8 years of applicable industry experience in clinical development with a minimum of 3 years managerial experience.

• Clinical Research certification is preferred, but not required.

Base Salary Compensation Range:

National salary range: $169,000/yr. - 192,000/yr.

Bay Area salary range: $186,000/yr. - $208,000/yr.