Job Description
Objective Reporting to the Vice President, Clinical Development, the Medical Director will lead clinical development strategy and clinical operations for active programs. Duties will include management of cross-functional, multidisciplinary study teams, and oversight for the design and execution of clinical trials. S/he will serve as the Medical Lead and primary Medical Monitor for clinical trials. The Medical Director will work closely with all matrixes of the team including scientists in discovery research, clinical operations, and regulatory affairs. The Medical Director will also participate in advisory meetings with opinion leaders and academic study investigators and will support interactions with Health Authorities. Essential Functions Lead the development of study protocols, statistical analysis plans, investigators brochures, and other key study documents in conjunction with Perspective Leadership and key advisors. Prepare the clinical development plans with support from cross functional team members. Perform regular data reviews (including e.g. PK, safety, efficacy). Provide leadership on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution and data analysis. Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate, and interface with regulatory authorities as needed. Communicate with and inspire key external stakeholders to facilitate the development and medical oversight of Perspective compounds. Stakeholders and mechanisms of outreach may include: Investigators, Medical Community (e.g., KOLs) Preparation and presentation of abstracts/oral presentations at conferences, and writing of manuscripts) Provide medical insight to Advisory Board meetings and develop learning materials for inter
