Medical Director, Clinical Development (Remote)

M.D./DO or equivalent with rare disease, pediatric, or neuroscience experience preferred. Board certification in a specialty is highly desired. 5+ years’ experience as a medical monitor in the pharmaceutical industry. Experience managing clinical trials and/or clinical development program(s). Experience working collaboratively within a multi-disciplinary team. Proven ability to interact with external experts and investigators. Experience in early-stage development programs. Demonstrated command working with FDA, MHRA and ICH GCP guidelines. Effective oral and written communication skills. Excellent interpersonal skills with demonstrated ability to work with a small growing team. Marked proficiency in clinical/medical writing. Experience designing mid- and late-phase clinical trials. Comfortability with advanced clinical trial design and statistical methodologies. Capable of analyzing research data and publications. Working knowledge of biostatistics. Working knowledge of GCP, scientific and clinical research methods and clinical study design.

Contribute to the development and execution of clinical development plans. Offer expert clinical advice and review clinical study data. Prepare reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects. Serve as a medical expert and stay current with research. Contribute to the design and oversight of clinical trials. Develop study protocols, case report forms, and informed consent documents. Collaborate with the regulatory team for submissions (INDs, NDAs, BLAs). Prepare and complete clinical study reports and investigator’s brochures. Contribute to Board meeting preparation. Provide medical oversight for clinical trials, including safety monitoring. Build and maintain relationships with key opinion leaders. Collaborate with other departments to ensure alignment on program objectives. Lead the development of scientific publications and presentations. Provide medical and development perspective into research programs. Support start-up activities for clinical studies. Serve as primary medical point of contact for sites and PIs. Interface with international regulatory authorities.