Associate Director, Clinical Operations - EyePoint Pharmaceuticals, Inc.

Be Seen and Heard at EyePoint Pharmaceuticals

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

The Associate Director, Clinical Operations is responsible for managing all aspects of multiple clinical trials with emphasis on CRO, vendor and internal team management to drive a high functioning and results- driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity. The role is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables, timelines, budgets, and resourcing. They proactively identify risks and implement mitigation strategies, driving success in clinical operations with a strategic vision and teamwork. The incumbent must have a demonstrated capacity to lead with minimal supervision, communicate effectively, think strategically, motivate a team and drive results.

This position will report to the VP, Clinical Operations and is located at our Watertown, MA site. We offer a hybrid work schedule.

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Lead clinical operations for assigned programs, ensuring compliance with GCP, ICH, and applicable regulations.
• Oversee global studies, providing direction to Clinical Trial Managers and CRO Study Teams
• Assist in the development of project timelines to meet departmental and corporate goals
• Track KPIs for assigned trials, including clinical reviews and data query resolution
• Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance
• Provide senior management with timely updates on progress and changes in scope
• Oversee the preparation and content of investigator meetings
• Coordinate site outreach and enrollment efforts
• Communicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and Finance
• Contribute to clinical study reports, Investigator's Brochures, protocols, and other regulatory documents
• Ensure the Clinical Trial Master File is updated and inspection ready
• Lead or co-lead the development of clinical documents and study-related plans
• Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team
• Provides input as the subject matter expert for the study during regulatory inspections
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Trains and manages CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements
• Monitors the status of clinical data collection of assigned clinical studies
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
• Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required
• Evaluates CRO and vendor performance for future work
• Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable
• Requests and critically evaluates proposals and change orders from CROs and vendors
• Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities

Primary skills and knowledge required include, but are not limited to the following:

Qualifications

• Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred
• Knowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research.
• Up to 20% domestic and/or international travel may be required
• Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not required
• Previous experience in Ophthalmology - clinical trial management, study coordination, COT, etc.
• Global clinical trial experience and the ability to lead/manage more than one clinical trial
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and
• meeting deadlines
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and
• demands
• Ability to work independently and take initiatives.
• Ability to work/communicate successfully within a cross-functional team
• Strong knowledge of applicable computer and project management software packages
• Familiarity with financial budgeting and forecasting or reporting
• Respectfully challenges current practices, decisions, or ideas to promote quality and efficiencies
• Excellent written and oral communication skills
• Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization

Level of Education Required:

• Bachelor’s degree

Preferred Field of Study:

• Scientific/Health Care related field

Number of Years of Experience in the Function and in the Industry:

• 10+ years’ experience working in clinical trials/operations within a pharmaceutical company or CRO or similar organization
• Experience of at least 5 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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