Medical Director/Sr Medical Director, Clinical Development
Watertown, MA
Job Type: Direct Hire | Recruiter: Jaime Gunning | Phone: 617.215.7066
Location: Remote, US
Length: Direct Hire
Job Description:
Our client is seeking a Sr. Medical Director, Clinical Development (Medical Monitor) to be the primary sponsor medical person of contact for their clinical trials.
Essential Duties and Responsibilities:
- 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:
- Minimum 10-15 years of experience in Ophthalmology
- Minimum of 2-4 years’ experience working in a biotech/pharmaceutical industry or CRO
- Medical degree (MD, DO or equivalent with a specialization in Ophthalmology).
- 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.
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- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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