Sr. Medical Director

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 leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

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