EyePoint
Senior Medical Director/Director, Clinical Development
EyePoint, Watertown, Massachusetts, us, 02472
Senior Medical Director/Director, Clinical Development
Join to apply for the
Senior Medical Director/Director, Clinical Development
role at
EyePoint 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
EyePoint Be Seen and Heard at EyePoint
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach were 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 EyePoint
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach were 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.
Theres 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 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 anothers differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.
EyePoint
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.
Seniority level
Seniority level
Director Employment type
Employment type
Full-time Job function
Job function
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Join to apply for the
Senior Medical Director/Director, Clinical Development
role at
EyePoint 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
EyePoint Be Seen and Heard at EyePoint
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach were 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 EyePoint
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach were 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.
Theres 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 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 anothers differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.
EyePoint
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.
Seniority level
Seniority level
Director Employment type
Employment type
Full-time Job function
Job function
Health Care Provider Referrals increase your chances of interviewing at EyePoint by 2x Get notified about new Senior Medical Director jobs in
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United States $450,000.00 - $525,000.00 2 days ago VP, Medical Affairs - US Biomedicine - Remote *PC 1473
United States $150,000.00 - $175,000.00 2 weeks ago Senior Medical Director, Medical Affairs - Bone
United States $307,600.00 - $380,000.00 5 days ago United States $280,000.00 - $320,000.00 2 weeks ago Director, Medical Engagement Excellence Oncology
United States $200,800.00 - $276,100.00 2 months ago Regional Medical Director, Specialty Care
United States $220,000.00 - $240,000.00 1 day ago Vice President, Medical Affairs, Oncology - US - Remote
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United States $264,400.00 - $363,550.00 4 weeks ago North Carolina, United States $280,000.00 - $320,000.00 2 weeks ago Director, Clinical Operations (Medical Affairs)
United States $204,000.00 - $255,000.00 2 weeks ago Director, Quality Assurance, Drug Product
Executive Director, Medical Affairs Strategy
Executive Director, Medical Affairs Strategy
United States $303,382 - $361,500 1 week ago Executive Director, Field Medical Affairs
Senior Regional Director, Medical Science Liaisons - West
Medical Director - Medical Communications
Executive Director Clinical Development - Breast Cancer
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr