Jobs · Healthcare

Medical Director

BioSpace · United States · 1 wk ago
RemoteRemoteHealthcare$278k–$310k/yrFull-time

General Summary

The Medical Director will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, with a focus 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

  • Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation.
  • Serve as medical monitor for clinical studies, ensuring patient safety and data integrity.
  • 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, commercial) to drive program success.
  • 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 the 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
    • 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
    • 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

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).

Pay

Base salary compensation range: $278,000 - 310,000

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 experience.

Benefits

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

Contact Information

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development.

We are located at:

  • 5858 Horton St. Suite 455
  • Emeryville, California 94608
  • United States

To apply, please visit our website: www.4dmoleculartherapeutics.com.

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