Senior Medical Director/Director, Clinical Development

Overview

Be Seen and Heard at EyePoint

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.

 

We are seeking a Sr/Medical Director, Clinical Development (Medical Monitor) to be the primary sponsor medical person of contact for our clinical trials. This person will report into the VP, Clinical Development. We offer a competitive salary, bonus structure and stock.

 

We offer a hybrid work schedule.

Responsibilities

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

 

• Provide sponsor medical oversight for ophthalmology clinical trials
• Represent sponsor for any emergency safety-related matters; in which CRO medical monitor would be primarily responsible.
• Conduct medical monitoring, coding, and data cleaning in collaboration with other functions; provide medical expertise during data listing reviews
• Monitor safety data from ongoing clinical trials, including adverse events, laboratory abnormalities, and other safety signals.
• Evaluate safety data in collaboration with the pharmacovigilance and clinical development team and make recommendations for appropriate actions, including protocol amendments and safety communications.
• Participate in safety review meetings, including data monitoring committee, and contribute to safety reporting requirements.
• Review clinical trial data, including efficacy endpoints, biomarkers, and imaging data.
• Contribute to and review eCRFs and CRF completion guidelines.
• Review of clinical trial protocols, investigator brochures, and other study-related documents.
• Support site investigators and study teams in collaboration with clinical operations in protocol implementation, training, and ongoing medical guidance.
• Support or prepare data interpretation and clinical trial reports.
• Assist in preparation of clinical sections of regulatory documents (INDs, IND annual reports, briefing packages, etc); collaboratively prepare for meetings with FDA/EMA/global agencies.

Qualifications

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

• Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
• Strong understanding of clinical trial design, methodology, and regulatory requirements.
• Knowledge of ophthalmic diseases, treatments, and diagnostic techniques.
• Experience with ophthalmic imaging modalities, such as OCT and fundus photography, is desirable.
• Familiarity with Good Clinical Practice (GCP) guidelines and ethical principles governing human subjects research.
• Experience in monitoring retinal trials and phase 3 global trials is highly preferred.

Level of Education Required:

• Medical degree (MD, DO or equivalent) with specialization in ophthalmology.

Number of Years of Experience in the Function and in the Industry:

• Minimum of 2-4 years’ experience working in a CRO or biotech/pharmaceutical industry.

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