Medical Director, Lung-Diseases

Location
Emeryville, CA
Posted
May 01, 2021
Discipline
Science/R&D, Pathology
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:
Reporting to the Chief Medical Officer, the Medical Director is accountable for the creation and execution of Clinical Development Plans in the lung-disease Therapeutic Area and is the company’s primary clinical champion for lung disease programs.
Responsibilities:
  • Leads multidisciplinary clinical 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, for study conduct, and for study readout
  • Organizes and leads scientific advisory board meetings. Interacts with external experts to gather input.
  • Serves as medical monitor on clinical studies.
  • Serves as the primary clinical author of development plans, study protocols, amendments, ICFs,  IBs, INDs, annual reports, CSRs, regulatory submissions / correspondence, and project-related documents. Accountable for the accuracy of all medical content of such documents.
  • Works with the research organization and the portfolio management team to identify and support new project opportunities.
  • Collaborates to identify program risks, and to create and implement mitigation strategies
  • Other duties as assigned

Qualifications:
  • Education:
  • Medical Degree (M.D.)
  • Board certification in pulmonology preferred.  Post-grad clinical training in allied fields also acceptable—these include infectious disease, pediatrics and immunology.

  • Experience:
  • Experience with gene therapy is a plus.
  • 5 + years of clinical research experience in the pharmaceutical/biotech industry

  • Skills:
  • Knowledge of ICH-GCP and FDA regulatory guidelines, and experience in establishing audit-readiness.
  • 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
  • Experience with co-authoring and proposing clinical study budgets
  • Experience with clinical vendor oversight

  • 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