Job description
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 medicine
GENERAL SUMMARY:
The Senior Medical Director is accountable for the design, execution, and analysis of clinical trials in the Ophthalmology Therapeutic Area.
MAJOR DUTIES & 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:
- 8+ 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.
- Experience writing clinical research protocols and acting as a medical monitor
- Experience in data analysis, data interpretation, and medical writing
Other Qualifications/Skills:
- Knowledge of ICH-GCP and FDA regulatory guidelines.
- Knowledge of international regulatory guidelines a plus.
- Effective written and verbal communication skills, including public speaking
Travel: 15% (3 days/month)
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $315,000/yr - $390,000/yr
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
