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Senior Medical Director
3 months ago
Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
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.
Company Differentiators:
• 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
GENERAL SUMMARY:
Reporting to the SVP Therapeutic Area Head-Ophthalmology, the Senior Medical Director is accountable for the design, execution, and analysis of clinical trials in the Ophthalmology Therapeutic Area.
RESPONSIBILITIES:
Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts
Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders 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.)
Residency training in Ophthalmology with a preference for subspecialty training in retina
Board certification a plus
Retina fellowship training a plus
Experience:
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.
Skills:
Knowledge of ICH-GCP and FDA regulatory guidelines.
Knowledge of international regulatory guidelines a plus.
Experience writing clinical research protocols and acting as a medical monitor
Experience in data analysis, data interpretation, and medical writing
Effective written and verbal communication skills, including public speaking
Ability to travel 15% (3 days/month)
Remote/hybrid acceptable but Local/Hybrid preferred
Compensation range:
Outside of Bay Area: $301k/yr - $365k/yr
Bay Area range: $347k/yr - $370k/yr
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
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
