Medical Director, Ophthalmology

Location
Emeryville, CA
Posted
May 01, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
This position reports to the SVP Clinical Ophthalmology. The Medical Director is accountable for strategic planning and execution of Clinical Development Plans.

Responsibilities
  • Accountable for delivery of study protocols, study conduct, study readout and responsible for execution of clinical programs
  • Lead clinical teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharmtox, drug safety, commercial, and alliance partners.
  • Act as medical monitor in clinical studies.
  • Interact with external experts to gather input. Organize scientific advisory board meetings.
  • Contribute to authoring study protocols, amendments, ICFs,  IBs, INDs, annual reports, CSRs, and other regulatory submissions  and project-related documents. Accountable for the medical content of documents.
  • Work with the research organization to identify and support new project opportunities.
  • Collaborate to identify program risks, create and implement mitigation strategies

Experience
  • Medical Degree (M.D.)
  • Board certification in ophthalmology preferred.
  • Experience:
  • Experience with retinal disease, imaging, psychophysics, or gene therapy a plus.
  • At least 3 years of Clinical Research Experience in the pharmaceutical/biotech industry.
  • Skills:
  • Knowledge of ICH-GCP and FDA regulatory guidelines.  Knowledge of international regulatory requirements a plus
  • Experience writing clinical research protocols and acting as a medical monitor
  • Experience in multiple phases of clinical research (Phase 1-3) preferred
  • Effective written and verbal communication skills
  • Physical Requirements:
  • Adhere to 4DMT COVID protocols and policy 

4DMT provides 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