EyePoint Pharmaceuticals, Inc.
Director, Clinical Operations
EyePoint Pharmaceuticals, Inc., Oklahoma City, Oklahoma, United States,
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 reports 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:
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
Provide input as the subject matter expert for the study during regulatory inspections
Manage escalation of study related issues and communicate as appropriate with management and other R&D functions
Anticipate potential study issues and prepare contingency plans with minimal oversight
Train and manage CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements
Monitor the status of clinical data collection of assigned clinical studies
Monitor progress of clinical activity and produce regular and ad hoc reports and presentations as required
Evaluate CRO and vendor performance for future work
Review budgets and contracts with CROs, vendors, and investigative sites, as applicable
Request and critically evaluate proposals and change orders from CROs and vendors
Maintain 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
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.
#LI-Hybrid
#J-18808-Ljbffr
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 reports 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:
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
Provide input as the subject matter expert for the study during regulatory inspections
Manage escalation of study related issues and communicate as appropriate with management and other R&D functions
Anticipate potential study issues and prepare contingency plans with minimal oversight
Train and manage CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements
Monitor the status of clinical data collection of assigned clinical studies
Monitor progress of clinical activity and produce regular and ad hoc reports and presentations as required
Evaluate CRO and vendor performance for future work
Review budgets and contracts with CROs, vendors, and investigative sites, as applicable
Request and critically evaluate proposals and change orders from CROs and vendors
Maintain 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
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.
#LI-Hybrid
#J-18808-Ljbffr