Full-Time Medical Director, Clinical Development

Overview: The Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies. The successful candidate will have direct medical responsibility for creating clinical development plans, designing clinical studies, writing protocols, providing CRO oversight and safety monitoring of clinical programs. The Medical Director will contribute collaboratively toward the clinical aspects of research and early-stage development programs, providing insight into treatment indications, patient populations, study designs and overall development strategies.

The Medical Director reports to Chief Medical Officer and is responsible for supporting clinical development, functioning as the medical lead and medical monitor for clinical trials, and working with cross-functional multidisciplinary study teams on clinical trial strategy, design, and execution. The ideal candidate will have experience as a medical monitor in early- to late-stage clinical trials. Ideal candidate would be based remote in eastern time zone.

Responsibilities:

• Contribute to the development and execution of comprehensive clinical development plans.
• Offer expert clinical advice.
• Review clinical study data and prepare reports, protocols, and development plans.
• Collaborate with early development research teams on clinical aspects and disease indications.
• Serve as a medical expert, staying current with research advancements.
• Contribute to the design and oversight of clinical trials, developing study protocols, case report forms, and informed consent documents, ensuring regulatory and ethical compliance.
• Collaborate with the regulatory team to prepare and submit regulatory documents (INDs, NDAs, BLAs).
• Collaborate with study team to prepare clinical study reports, investigator’s brochures, and Data Safety Update Reports.
• Contribute to Board meeting preparation.
• Provide medical oversight for current and future clinical trials, including safety monitoring, data analysis, and interpretation of results.
• Build and maintain relationships with key opinion leaders (KOLs) and academic institutions.
• Collaborate with other departments (clinical operations, technical operations/CMC, translational research, and regulatory affairs).
• Lead the development of scientific publications, presentations, and educational materials.
• Provide medical, disease-specific, and development perspective into research programs.
• Support start-up activities (informed consent forms, eCRF design, etc.).
• Serve as primary medical point of contact for sites and PIs.
• Interface with international regulatory authorities.

Qualifications:

• M.D./DO or equivalent with rare disease, pediatric, or neuroscience experience preferred.
• Board certification in a specialty highly desired.
• 5+ years’ experience as a medical monitor in the pharmaceutical industry.
• Experience managing clinical trials and/or clinical development programs.
• Experience working collaboratively in multi-disciplinary teams.
• Experience in early-stage development programs.
• Command of FDA, MHRA, and ICH GCP guidelines.
• Effective oral and written communication skills.
• Excellent interpersonal skills.
• Marked proficiency in clinical/medical writing.
• Experience designing mid- and late-phase clinical trials.
• Capable of analyzing research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design.

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