We are an ophthalmology focused company committed todeveloping and commercializing innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders.
EyePoint Company Values include:
Success begins with our People – our employees are valued, relied upon and key to our company’s success
Patient First – above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patients
Integrity– we are always honest, open, ethical and fair
Results-Driven– we are decisive and act with a sense of urgency against clear and aggressive goals
Innovation – we strive for continuous improvement through thoughtful risk-taking
Team Focus– we work and communicate in a collaborative, respectful and inclusive fashion
Diversity & Inclusion - We commit to diversity in our staff and embrace inclusion and acceptance of others without bias
The Director, Clinical Operations leads the planning, coordinating and execution of multiple clinical trials in accordance with project milestones, within budget and with high quality in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and EyePoint SOPs.
The Director is accountable for the study level execution of Clinical Operations study deliverables from Phase 1 through Phase 4. The Director will be responsible for managing both internal resources as well as outsourced functions critical to the execution of the clinical trials along with identifying operational risks and developing risk mitigation strategies.
This position reports to the Chief Medical Officer.
Responsibilities include, but are not limited to the following:
Direct and oversee the operation of the clinical program(s) to ensure compliance with regulatory requirements.
Ensure adequacy of data acquisition and management, and timely completion of studies and associated projects.
Develops project timelines, to meet department and corporate goals for timely initiation and completion of clinical studies.
Identify study operational risks and develop and implement mitigation strategies for clinical studies.
Provide senior management with timely updates on progress and changes in scope and schedule.
Ensure adequate study resources are in place to successfully complete clinical project and programs on-time and on-budget.
Partner effectively to ensure regular and effective communication with key stakeholders including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply Chain, Clinical Affairs, Legal, Finance, and others, as necessary.
Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines and make recommendations to senior management.
Oversee study start up activities including site budget and contract negotiations.
Track and manage site payments according to contract.
Coordinate with departmental teams to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders.
Coordinate and contribute to writing and review of study protocol, clinical study reports, investigator’s brochure and other clinical documents.
Oversees study site selection and recruitment strategies.
Oversee vendor and site qualification activities in conjunction with Quality Assurance.
Negotiate and manage vendor contracts.
Coordinate and responsible for oversight of investigator meetings slides and content.
Oversee management and maintenance of Trial Master File.
Assure GCP audit readiness. Support regulatory audits and inspections.
May contribute to the development of SOPs and other procedural documents.
Mentor junior clinical operations team members
Must have excellent accountability, facilitation, organizational, analytical, and time management skills.
Experience considered relevant includes clinical research in Biotech, Pharmaceutical or Contract Research Organization.
In-depth experience with drug development issues.
A good understanding of GCPs and ICH Guidelines.
Must be detailed oriented, possess excellent time management skills, be self-directed, well organized, and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
Excellent writing and editing skills with meticulous attention to detail with solid writing and organizational skills.
Must be able to work as a team member, multi-task, and maintain day-to-day activities while being responsive to changing priorities.
Must possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others positively and collaboratively; able to communicate with a sense of urgency to internal and external customers.
Subject to COVID-related conditions and restrictions, must be willing to travel domestically
Level of Education Required/Preferred Field of Study:
B.A. or advanced scientific degree (e.g., MS in biological sciences, Pharm D or related discipline).
Number of Years of Experience in the Function and in the Industry:
At least 15 years’ experience in clinical operations with 5 years’ experience leading and managing the execution of early phase clinical trials from start-up through clinical study report generation.
Prior experience managing third parties and external service providers (worldwide) and consultants.
Experience in clinical development of ophthalmic products.
Preferred Computer Skills:
Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint and Microsoft Project.
Internal Number: 2020-1151
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders.