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GENERAL SUMMARYReporting to the Chief Medical Officer, the VP Clinical Development, 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 intravitreally delivered genetic medicines for the treatment of the most common causes of irreversible blindness. The VP, Clinical Development will be a primary point person for medical oversight of clinical studies, with responsibilities including medical monitoring, review and interpretation of clinical trial data, clinical trial design, protocol development, and drafting of key clinical documents such as protocols, CSRs, briefing packages, INDs, NDAs, BLAs, MAAs, and other regulatory documents. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.
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.
QUALIFICATIONS: Education:
- MD Degree
- Clinical training in Ophthalmology preferred
- Retina fellowship training a plus
- Board Certification (or equivalent) preferred
Experience:
- 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 submission(s). Drug approval(s) a plus.
- Experience with gene therapy, other areas of Drug Development and commercialization is a plus.
Skills:- 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 highly preferred.
- 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
- Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.
- 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.
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $350,000 - $430,000Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
