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 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.  The successful candidate will immediately assume leadership for the execution of simultaneous clinical trials focusing on timeline, 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. This individual will 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 is reporting to the VP, Clinical Operations and 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
• Represent Clinical Operations on cross-functional program teams for all assigned programs

• 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
• 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
• 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
• Knowledge of current FDA and local IRBs regulatory requirements and guidelines governing clinical research
• Experience with managing direct reports within a cross-functional matrix
• Previous experience in Ophthalmology - clinical trial management, study coordination, COT, etc. preferred
• 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
• 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
• Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not required
• Up to 20% domestic and/or international travel may be required

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.
• Previous experience as an Associate Director/Director of Clinical Operations or similar position within a pharmaceutical company or CRO. Significant experience as a Senior CTM may also be considered.

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.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

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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