About the position
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, and transforming ocular drug delivery. This position may be in Watertown, MA or remote. The Sr. Dir, Clinical Development will report to the Chief Medical Officer and will provide support to the clinical development team and EyePoint drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of data from early to late-stage clinical development programs. This leadership role will be responsible for the clinical development function; direct reports may include one or more physicians and clinical scientists. This individual will be responsible for ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
Responsibilities
- Lead the clinical development function and for one or more development assets
- Participate in clinical leadership team meetings and provide medical guidance in the execution of clinical trials
- Author/review, in collaboration with other EyePoint functions, protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs
- Independently review and interpret clinical trial data
- Provide mentorship and development opportunities to others within EyePoint
- Responsible for medical monitoring of one or more clinical trials
- Contribute to Clinical Development Plan for one or more assets
- Work cross-functionally with clinical operations, biometrics and data management, drug safety, drug formulation development, regulatory, pre-clinical and clinical pharmacology, medical affairs
- Evaluate scientific information and new ideas to assist in identifying new research opportunities
- Contribute to determining global strategy for development of clinical development assets
- Prepare manuscripts, abstracts and presentations for scientific meetings
Requirements
- 10+ years' experience in ophthalmology clinical development, with experience in small and large pharma
- Experience representing clinical development in regulatory interactions, including NDA/MAA submission
- Global clinical trial experience, including 3 studies
- Experience supervising other clinical scientists and supporting them in co-authoring study and regulatory documents
- Extensive knowledge of ophthalmology clinical drug development, including FDA regulations, statistics, safety
- Experience in working with small molecule targeted agents; experience with VEGF inhibitors or other antiangiogenic agents a plus
- Excellent written and verbal communication skills
- Willing and able to travel, as needed
