Medical Director, Ophtalmology
4D Molecular Therapeutics
At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
The Medical Director, Ophtolmology with contribute to the design, start-up, execution, analysis, and communication of the clinical studies in Ophthalmology. This role will collaborate with clinical operations, biometrics, data management, regulatory affairs, CMC, pharmtox, drug safety, commercial, and alliance partners.
- Act as medical monitor in clinical ophthalmology studies with a focus on safety, data review and analysis of emerging data (30%)
- Contribute to study related documents including but not limited to study synopsis, protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, and other regulatory submissions and project-related documents. Accountable for the medical content of documents. (30%)
- Analyze, interpret, and organize data for presentations and publications (20%)
- Interact with external experts to gather input. Organize scientific advisory board meetings and data safety monitoring committee meetings (5%)
- Maintain a high level of clinical and scientific expertise in ophthalmologic disease area(s) by reviewing the literature and attending medical/scientific meetings (5%)
- Ability to communicate with Investigators and research site staff (5%)
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
- Medical Degree (M.D.) with clinical experience
- Clinical residency training in ophthalmology required.
- Experience with retinal disease, retinal imaging, or gene therapy a plus.
- 3-5 years of experience in clinical research in the pharmaceutical/biotech industry.
- 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 preferred.
- Experience in multiple phases of clinical research (Phase 1-3) preferred
- Effective written and verbal communication skills
- Able to work in a fast-paced, team-based environment; able to multitask and be a self-starter
- Able and willing to travel
Bay Area Range
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.