Vice President, Late Stage Ophthalmology - DME

4D Molecular Therapeutics•Emeryville, CA

About The Position

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: Reporting to the Chief Medical Officer the VP Late Stage Ophthalmology provides strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development. We seek an experienced physician to play a critical role at 4DMT as we spearhead the introduction of the first intravitreally delivered genetic medicines for the treatment of the most common causes of irreversible blindness. The VP, Late Stage Ophthalmology will be the primary point person for medical oversight of clinical studies with responsibilities to include medical monitoring, review and interpretation of clinical trial data, clinical trial design, protocol development, and drafting of key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.

Requirements

M.D. Degree
Clinical training in Ophthalmology
Board Certification (or equivalent)
Minimum of 8 years of biopharma industry experience in drug development
Phase 3 experience in retinal disease (s), diabetic eye disease highly preferred
Experience with NDA, BLA or MAA submission(s). Drug approval(s) a plus.
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
Prior Clinical Trial experience in Retina, Diabetic Eye Disease
Experience in participating or leading global regulatory interactions
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 in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory.
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.
Able to ensure accountability
Able to manage conflict
Comfortable managing ambiguity
Strong clinical and scientific knowledge of ophthalmology (and retinal disease in particular)
Track record of developing talent
Record of cultivating and managing internal and external cross-functional collaborations.
Demonstrates high integrity.
Experience in successfully presenting and interacting with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC
Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.

Nice To Haves

Retina fellowship training a plus
Experience with gene therapy, other areas of Drug Development and commercialization is a plus

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 personal 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 Domestic and Internationally as required ~20%