Director, Clinical Development Scientist

MD, PhD, or PharmD required. Experience in clinical development. Experience in rare diseases or neurology 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 with some supervision. 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 and external vendors.

Provide clinical leadership and strategic medical input for clinical deliverables. Lead development of clinical sections for regulatory documents. Drive execution of the program and/or clinical trial. Support the Clinical Development program lead with medical input into CDP and CTP reviews. Conduct literature review, 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 assigned clinical trials, including data and safety review. Work with stakeholders to ensure timely recruitment.