Director, Clinical Development Scientist

MD, PhD, or PharmD required. Experience in clinical development required. Experience in rare diseases or neurology is highly preferred. Proven ability to work with cross functional teams, study vendors, and clinical trial sites. Strong business communication skills, written and verbal. Comfortable with giving presentations internally and externally. Thorough understanding of GCP/regulatory requirements. Ability to identify challenges and risks and implement appropriate actions. Highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision. Ability to coordinate activities of internal cross-functional study team as well as external vendors. Open-mindedness to listen to ideas and seek guidance.

Provide clinical leadership and strategic medical input for clinical deliverables. Lead development of clinical sections for regulatory documents. Drive program and/or clinical trial execution. Support Clinical Development program lead with medical input into CDP and CTP reviews. Conduct literature reviews, KOL interactions, and present clinical development plans. Lead protocol development for new indications. Support and lead interactions with external and internal partners. Medical monitoring of clinical trials, data and safety review. Oversee conduct of clinical trials in collaboration with operations and external partners. Ensure timely recruitment in collaboration with clinical sites and investigators.