Vice President, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic and operational direction for the global advancement of ophthalmic genetic therapies within Drug Development.

• Act as the primary medical monitor for various ophthalmology clinical trials, ensuring the safety of patients, integrity of data, and adherence to protocols.

• Lead and mentor a team of medical monitors.

• Offer medical guidance for cross-functional workstreams, including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.

• Oversee the creation of development plans, study protocols, amendments, informed consent forms (ICFs), investigator brochures (IBs), investigational new drug applications (INDs), annual reports, clinical study reports (CSRs), regulatory response documents, and other submissions.

• Collaborate with Clinical Operations, maintaining accountability for the execution, timelines, and critical deliverables of clinical trials.

• Ensure compliance with standard operating procedures (SOPs), International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), and relevant regulatory guidelines.

• Provide medical leadership during internal audits and regulatory inspections.

• Prepare materials for Advisory Board and Board of Directors meetings.

• Represent 4DMT and lead engagements with prospective partners.

• Advocate for the Ophthalmology Therapeutic Area with patients, advocacy organizations, external experts, investors, and the ophthalmic and biotech communities.

• Travel domestically and internationally as necessary, approximately 20% of the time.

⛳️ Requirements

• MD degree.

• At least 8 years of experience in the biopharmaceutical industry focused on drug development.

• Experience in Phase 3 ophthalmology, with a strong preference for retinal disease expertise.

• Familiarity with New Drug Application (NDA), Biologics License Application (BLA), or Marketing Authorization Application (MAA) submissions.

• Background in gene therapy, drug development, and commercialization is advantageous.

• Strong interpersonal, written, and verbal communication skills.

• Exceptional analytical, problem-solving, and strategic planning abilities.

• Current knowledge of the competitive landscape in ophthalmology, particularly related to retina.

• Capability to comprehend and convey complex data into essential messages.

• Proficient in planning and executing clinical trials with high-quality results within set timelines.

• Proven ability to collaborate effectively across pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.

• Experience engaging with and presenting to the Ophthalmic Retina Community and regulatory bodies in the US, EU, and APAC.

• Understanding of FDA, EMA, ICH, and GCP guidelines.

• Experience in building and leading teams in a matrixed environment.

• Demonstrated history of talent development.

• High integrity.

🏝️ Benefits

• Base salary compensation range of $350,000 - $430,000.

• Remote work arrangement.

• Equal employment opportunities.

• Approximately 20% travel opportunities domestically and internationally.