Vice President, Late Stage Ophthalmology - DME
4D Molecular Therapeutics
2 months ago
Remote friendly (Emeryville, CA)
United States
$350,000 - $440,000 USD yearly
Clinical Research and Development
General Summary:
- Reporting to the Chief Medical Officer, the VP Late Stage Ophthalmology provides strategic and operational leadership for global development of ophthalmic genetic medicines.
- Primary medical oversight of clinical studies, including medical monitoring, interpretation of clinical trial data, clinical trial design, protocol development, and drafting key clinical documents (protocol, CSR, briefing package, IND, NDA, BLA, etc.).
Responsibilities:
- Serve as primary medical monitor for multiple ophthalmology clinical trials (patient safety, data integrity, protocol adherence).
- Direct and mentor a team of medical monitors; accountable for real-time monitoring and timely delivery of clinical trial outputs.
- Provide medical leadership for cross-functional workstreams (pharmacovigilance, biostatistics, clinical operations, regulatory affairs).
- Lead teams for development plans and regulatory/document deliverables (protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory responses).
- Collaborate with Clinical Operations; accountable for clinical trial conduct and key deliverable timelines.
- Ensure compliance with SOPs and adhere to ICH/GCP and relevant regulatory guidelines.
- Lead internal audits and support regulatory inspections.
- Assist with Advisory Board and Board materials.
- Represent the company and Ophthalmology Therapeutic Area with partners and key external stakeholders.
- Travel ~20% as required.
Qualifications:
Education:
- M.D.
- Clinical training in Ophthalmology
- Board Certification (or equivalent)
- Retina fellowship training (plus)
Experience:
- 8+ years biopharma industry experience in drug development
- Phase 3 experience in retinal disease; diabetic eye disease (highly preferred)
- NDA/BLA/MAA submission experience; drug approvals (plus)
- Gene therapy and commercialization (plus)
Skills/Required Abilities:
- Strong written/verbal communication; strong interpersonal skills
- Analytical, problem-solving, strategic planning skills; ability to prioritize
- Ability to plan and execute clinical trials and work effectively cross-functionally
- Ability to translate complex data into key messages
- Understanding of ophthalmology/retinal disease and up-to-date retina competitive landscape
- Experience with global regulatory interactions (US/EU/APAC)
- Integrated understanding of FDA/EMA/ICH/GCP; prior FDA/EMA interactions (desirable)
- Ability to thrive in fast-paced, matrixed environments; manage conflict and ambiguity; attention to detail and high integrity
Compensation:
- Base salary range: $350,000–$440,000 (final offer depends on geography, experience, and skills).
- Reporting to the Chief Medical Officer, the VP Late Stage Ophthalmology provides strategic and operational leadership for global development of ophthalmic genetic medicines.
- Primary medical oversight of clinical studies, including medical monitoring, interpretation of clinical trial data, clinical trial design, protocol development, and drafting key clinical documents (protocol, CSR, briefing package, IND, NDA, BLA, etc.).
Responsibilities:
- Serve as primary medical monitor for multiple ophthalmology clinical trials (patient safety, data integrity, protocol adherence).
- Direct and mentor a team of medical monitors; accountable for real-time monitoring and timely delivery of clinical trial outputs.
- Provide medical leadership for cross-functional workstreams (pharmacovigilance, biostatistics, clinical operations, regulatory affairs).
- Lead teams for development plans and regulatory/document deliverables (protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory responses).
- Collaborate with Clinical Operations; accountable for clinical trial conduct and key deliverable timelines.
- Ensure compliance with SOPs and adhere to ICH/GCP and relevant regulatory guidelines.
- Lead internal audits and support regulatory inspections.
- Assist with Advisory Board and Board materials.
- Represent the company and Ophthalmology Therapeutic Area with partners and key external stakeholders.
- Travel ~20% as required.
Qualifications:
Education:
- M.D.
- Clinical training in Ophthalmology
- Board Certification (or equivalent)
- Retina fellowship training (plus)
Experience:
- 8+ years biopharma industry experience in drug development
- Phase 3 experience in retinal disease; diabetic eye disease (highly preferred)
- NDA/BLA/MAA submission experience; drug approvals (plus)
- Gene therapy and commercialization (plus)
Skills/Required Abilities:
- Strong written/verbal communication; strong interpersonal skills
- Analytical, problem-solving, strategic planning skills; ability to prioritize
- Ability to plan and execute clinical trials and work effectively cross-functionally
- Ability to translate complex data into key messages
- Understanding of ophthalmology/retinal disease and up-to-date retina competitive landscape
- Experience with global regulatory interactions (US/EU/APAC)
- Integrated understanding of FDA/EMA/ICH/GCP; prior FDA/EMA interactions (desirable)
- Ability to thrive in fast-paced, matrixed environments; manage conflict and ambiguity; attention to detail and high integrity
Compensation:
- Base salary range: $350,000–$440,000 (final offer depends on geography, experience, and skills).