Associate Director, Clinical Operations (Retina)

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.

- 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 (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.

- 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.

- 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

- Ability to be flexible and adaptable to changing business needs

- Must be able to write clearly and summarize information effectively

- Must be able to present complex information to various audiences