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Medical Director
4D Molecular TherapeuticsMedical Director leading clinical trials in ophthalmology at 4D Molecular Therapeutics. Designing, executing, and analyzing clinical studies with a focus on retina programs.
Core Competencies
Role fitCore Competencies
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Demonstrates expertise in leading clinical strategy and execution for ophthalmology trials, with a strong focus on protocol development, data interpretation, and regulatory submissions. Possesses extensive experience in clinical research, particularly in retina studies, and a solid understanding of ICH-GCP and FDA guidelines.
Highest-signal resume keywords
Medical Degree (M.D., OD, PhD, PharmD)Clinical Ophthalmology ResearchPhase 3 Retina Clinical TrialsData Analysis and InterpretationICH-GCP and FDA Regulatory Knowledge
ATS Keywords
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Hard Skills
Protocol DevelopmentClinical Document AuthoringMedical MonitoringData InterpretationClinical Research Protocol WritingNDA/BLA/MAA SubmissionGene Therapy ExperienceClinical Trial OversightRisk MitigationPortfolio Development
Soft Skills
Effective CommunicationPublic SpeakingCollaborationAdvisory Board OrganizationCross-Functional Team Engagement
Certifications & Qualifications
Board CertificationRetina Fellowship Training
Industry Keywords
Ophthalmology TrialsBiopharmaceutical IndustryClinical OperationsRegulatory SubmissionsScientific CommunicationsPatient SafetyData IntegrityInternational Regulatory Guidelines
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation.
- Serve as medical monitor for clinical studies, ensuring patient safety and data integrity.
- Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions.
- Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success.
- Engage with external experts, organize advisory boards, and contribute to scientific and medical communications.
- Identify and mitigate clinical and programmatic risks.
- Support portfolio development and evaluation of new clinical opportunities.
- Represent the company in regulatory and scientific forums as needed.
Requirements
What you’ll need- Medical Degree (M.D.), OD, PhD, PharmD or equivalent
- Residency training in Ophthalmology with a preference for subspecialty training in retina
- Board certification a plus
- Retina fellowship training a plus
- 5+ years of clinical ophthalmology research in the biopharmaceutical industry
- Experience with Phase 3 retina clinical trials
- Experience with gene therapy a plus
- Experience in other phases (Phase 1, 2, 4) of clinical research a plus.
- Experience with NDA/BLA/MAA submission a plus.
- Experience writing clinical research protocols and acting as a medical monitor
- Experience in data analysis, data interpretation, and medical writing
- Knowledge of ICH-GCP and FDA regulatory guidelines.
- Knowledge of international regulatory guidelines a plus.
- Effective written and verbal communication skills, including public speaking.
Benefits
Comp & perks- Equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities