Senior Medical Director​/Director, Clinical Development

Senior Medical Director/Director, Clinical Development

Join to apply for the Senior Medical Director/Director, Clinical Development role at Eye Point

Continue with Google Continue with Google

Senior Medical Director/Director, Clinical Development

Join to apply for the Senior Medical Director/Director, Clinical Development role at Eye Point

Be Seen and Heard at Eye Point

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

Be Seen and Heard at Eye Point

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 Eye Point

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.

This position is remote.

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; p rovide 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).

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…