4D Molecular Therapeutics
Executive Medical Director, (Retina Program)
Remote, United States · Director
Sponsorship not specified$350k-$398kDetected 7 days ago
GCPData AnalysisComplianceRecruitingClinical TrialsFDA RegulatoryCRISPRPharmacovigilanceResearchExperimental DesignLeadershipCommunicationPublic SpeakingRegulatory Affairs
About the role
- Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team.
- No unsolicited resumes will be accepted.
- The 4DMT Talent Acquisition team must expressly engage agencies on any requisition.
Responsibilities
- Serve as the clinical lead for Phase 1 retina clinical trials, including study design, protocol development, dose escalation strategy, and safety oversight
- Maintain accountability for study execution, data interpretation, and clinical readouts, including early signal detection and go/no-go recommendations
- Lead cross-functional study teams (clinical operations, clinical science, biometrics, regulatory, safety, CMC, etc.) to ensure high-quality and timely trial delivery
- Provides clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners
- Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts
- Lead development and implementation of biomarker strategies for GA and broader retina programs
- Collaborate with research and translational teams to identify, validate, and integrate imaging, molecular, and functional biomarkers into early-phase trials
- Ensure biomarkers are aligned with mechanism of action, dose selection, and clinical endpoints to support decision-making and regulatory strategy
- Ensure accuracy, scientific rigor, and regulatory compliance of all clinical documents
- Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input.
Requirements
- 10+ years of clinical ophthalmology research in the biopharmaceutical industry
- Experience with gene therapy clinical studies
- Experience in other phases (Phase 2, 3) of clinical research.
- Experience with NDA/BLA/MAA submission planning and execution
Nice to have
- Residency training in Ophthalmology with a preference for subspecialty training in retina
- Board certification/retina fellowship training are a plus
Skills
- Knowledge of ICH-GCP and FDA regulatory guidelines.
- Knowledge of international regulatory guidelines
- Effective written and verbal communication skills, including public speaking
- Travel: up to 20%
- Physical Requirements and
- Other Qualifications/Skills:
Compensation
- Please 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.
- $350,000 - 398,000
Benefits
- Serve as medical monitor for assigned studies, ensuring subject safety and data integrity
- Lead clinical contributions to IND submissions and early regulatory interactions, including Health Authority meetings for Phase 1 programs
Equal opportunity
- Employer/Protected Veterans/Individuals with Disabilities
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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