Attention recruitment agencies:
All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly 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. 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 medicineGENERAL 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.
*This is a REMOTE role.*
RESPONSIBILITIES:
- Provides clinical leadership to multidisciplinary study execution 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, 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: $301k/yr - $370k/yrPlease 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 experience4DMT 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
