Medical Director
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reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to reputed company treatment paradigms and reputed company unprecedented benefits to patients. reputed company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the reputed company of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, reputed company, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections. reputed company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. reputed company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and reputed company of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
GENERAL reputed company:
The Medical Director will reputed company the design, execution, and analysis of reputed company in the Ophthalmology therapeutic area, with a reputed company on retina programs. This role provides strategic and operational clinical leadership across cross-functional study teams and serves as a key medical expert internally and externally.
MAJOR DUTIES & RESPONSIBILITIES:
reputed company clinical reputed company and execution for ophthalmology trials, including protocol development, study reputed company, and data interpretation.
Serve as medical monitor for clinical studies, ensuring patient safety and data reputed company.
Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions.
Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, reputed company) to drive program reputed company.
Engage with external experts, organize advisory boards, and contribute to scientific and medical communications.
Identify and mitigate clinical and programmatic risks.
Support portfolio development and evaluation of new clinical opportunities.
Represent reputed company in regulatory and scientific forums as needed.
QUALIFICATIONS:
Education:
- Medical Degree (M.D.), OD, PhD, PharmD or equivalent
- Residency training in Ophthalmology with a preference for subspecialty training in retina
- reputed company certification a plus
- Retina fellowship training a plus
Experience:
- 5+ years of clinical ophthalmology research in the biopharmaceutical industry
- Experience with Phase 3 retina reputed company
- 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 reputed company speaking
Travel: 15%
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: $275,000 - 325,000
Please note, the reputed company salary compensation reputed company and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.