Vice President, Clinical Development

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $350k - $430k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Provide strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development • Serve as the primary medical monitor for multiple ophthalmology clinical trials, overseeing patient safety, data integrity, and protocol adherence • Direct and mentor a team of medical monitors • Provide medical leadership for cross-functional workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs • Lead development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents, and other submissions • Collaborate with Clinical Operations and remain accountable for clinical trial conduct, timelines, and key deliverables • Maintain compliance with SOPs, ICH, GCP, and relevant regulatory guidelines • Provide medical leadership for internal audits and regulatory inspections • Prepare materials for Advisory Board and Board of Directors meetings • Represent 4DMT and lead interactions with potential partners • Represent the Ophthalmology Therapeutic Area with patients, advocacy groups, external experts, investors, and ophthalmic and biotech communities • Travel domestically and internationally as required, approximately 20%

🎯 Requirements

• MD Degree • Minimum of 8 years of biopharma industry experience in drug development • Phase 3 ophthalmology experience; retinal disease highly preferred • Experience with NDA, BLA or MAA submissions • Experience with gene therapy, drug development, and commercialization is a plus • Strong interpersonal, written, and verbal communication skills • Excellent analytical, problem-solving, and strategic planning skills • Current understanding of the ophthalmic competitive landscape, especially retina • Ability to understand and translate complex data into key messages • Ability to plan and conduct clinical trials with high-quality execution and results within established timelines • Track record working effectively across pharmacovigilance, biostatistics, clinical operations, and regulatory affairs • Experience presenting to and interacting with the Ophthalmic Retina Community and regulatory authorities in the US, EU, and APAC • Understanding of FDA, EMA, ICH, and GCP guidelines • Experience building and leading teams in a matrixed environment • Track record of developing talent • 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