Note: The job is a remote job and is open to candidates in USA. 4D Molecular Therapeutics is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The VP Clinical Development, Ophthalmology will provide strategic and operational leadership for the global development of ophthalmic genetic medicines, overseeing clinical trials and ensuring compliance with regulatory standards.
Responsibilities
- Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence throughout study execution
- Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review, while maintaining accountability for real-time monitoring activities and timely delivery of critical clinical trial outputs
- Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc
- Provide oversight and lead teams responsible for development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents, and other regulatory submissions or documents as appropriate
- Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables
- Keep up to date with compliance, SOPs and adhere to ICH, GCP, and relevant regulatory guidelines
- Provide medical leadership for internal audits and regulatory inspections
- Assist in preparation of materials for Advisory Board meetings, BOD meetings, etc
- Represent 4DMT and lead interactions and collaborations with potential partners
- Represent the Ophthalmology Therapeutic Area with key external stakeholders, including patients and patient advocacy groups, external experts, investors, and the ophthalmic and biotech business communities
- Travel domestically and internationally as required, approximately 20%. Other duties as assigned; nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
Skills
- MD Degree
- Minimum of 8 years of biopharma industry experience in drug development
- Strong interpersonal skills and high emotional coefficient
- Highly effective written and verbal communication skills
- Excellent analytical, problem-solving and strategic planning skills
- Up to date understanding of the ophthalmic competitive landscape with a focus on retina
- Ability to understand and translate complex data to key messages
- Ability to thrive in a fast-paced environment
- Proven ability to prioritize effectively
- Proven ability to plan and conduct clinical trials ensuring high-quality trial execution and results within established timelines; demonstrated track record working effectively in cross-functional teams and workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs
- Experience in successfully presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC
- Track record of thinking strategically and executing to strategy
- Demonstrated success in influencing colleagues and senior leaders in various departments
- Experience building and leading teams and driving engagement in a matrixed environment
- Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
- Track record of developing talent
- Demonstrates high integrity
- Clinical training in Ophthalmology preferred
- Retina fellowship training a plus
- Board Certification (or equivalent) preferred
- Phase 3 ophthalmology experience; retinal disease highly preferred
- Experience with NDA, BLA or MAA submission(s). Drug approval(s) a plus
- Experience with gene therapy, other areas of Drug Development and commercialization is a plus
- Prior clinical trial experience in retina highly preferred
- Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable
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