Sr. Medical Director

Attention recruitment agencies: reputed company agency inquiries are vetted through 4DMT’s internal reputed company. No unsolicited resumes will be accepted. The 4DMT reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with 4DMT in the reputed company.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed reputed company for targeted genetic medicines. We reputed company to unlock the full potential of gene therapy using our platform, Therapeutic reputed company reputed company (TVE), which combines the power of directed reputed company with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved reputed company for use in our products. We reputed company key features of our targeted and evolved reputed company will help us create targeted product candidates with improved therapeutic reputed company. These reputed company will allow us to treat a broad reputed company of large market diseases, unlike most reputed company genetic medicines that generally reputed company on rare or small market diseases.

Company Differentiators:

• Fully integrated clinical-phase company with internal manufacturing • Demonstrated ability to reputed company rapidly from idea to IND • Five candidate products in the clinic and two declared reputed company-clinical programs • Robust technology and IP reputed company, 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 reputed company genetic medicine

GENERAL reputed company:

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, reputed company, and reputed company partners
• Has reputed company accountability on the study teams for delivery of study protocols, study conduct, and study readouts
• Organizes and leads scientific advisory reputed company meetings. Interacts with external experts and stakeholders to reputed company 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-reputed company documents. Accountable for the accuracy of reputed company 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
• reputed company 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 reputed company by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

reputed company salary compensation reputed company: $315,000/yr - $390,000/yr

4DMT provides equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, 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

Originally posted on Himalayas

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