Vice President, Clinical Development
4
4DMTBiotechnology
Remote, United StatesFull-TimeVp
Salary350,000 - 430,000 USD per year
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Job Details
- Experience
- Minimum of 8 years of biopharma industry experience in drug development.
- Required Skills
- GCP
Requirements
- MD degree required.
- Clinical training in Ophthalmology preferred.
- Retina fellowship training a plus.
- Board Certification or equivalent preferred.
- Minimum of 8 years of biopharma industry experience in drug development.
- Phase 3 ophthalmology experience, with retinal disease experience highly preferred.
- Experience with NDA, BLA, or MAA submissions.
- Knowledge of FDA, EMA, ICH, and GCP guidelines.
- Experience building and leading teams in a matrixed environment.
- Proven ability to plan and conduct clinical trials ensuring high-quality execution.
- Ability to present and interact with the Ophthalmic Retina Community and regulatory authorities.
- Ability to travel domestically and internationally as required, approximately 20%.
Responsibilities
- Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence.
- Direct and mentor a team of medical monitors to ensure high standards of medical oversight and real-time trial execution.
- Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
- Lead teams responsible for development plans, study protocols, ICFs, IBs, INDs, CSRs, and other critical regulatory submissions.
- Collaborate with Clinical Operations to ensure clinical trial conduct and meeting project timelines.
- Provide medical leadership for internal audits and regulatory inspections.
- Represent the company and the Ophthalmology Therapeutic Area to external stakeholders, including patients, advocacy groups, and regulatory authorities.
- Assist in the preparation of materials for Advisory Board and Board of Directors meetings.
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