Associate Director, Clinical Operations

Overview:

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 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.

Responsibilities:

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

• 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

Qualifications:

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

• 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.

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

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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