Consulting Medical Director/Sr MD. Clinical Development

Position:Sr. Medical Director, Clinical Development

Location:Remote, US

Length:6 Month Contract

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.
  

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 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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