Senior Director, Regulatory Strategy Leader-Oncology

Job Title: Senior Director, Regulatory Strategy Leader-Oncology Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Job Overview- Provide leadership and advice on the development of optimum regulatory and biostatistical strategies for drug development, product lifecycle management and portfolio management, particularly focussed on emerging biopharmaceutical company customer goals. Provides strategic regulatory and biostatistical advice towards efficient clinical development and navigation of US & European regulatory frameworks. Minimal participation in project-related work, as necessary as a subject matter expert. Provide scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities. Support policy initiatives around the organization. Provide thought leadership by participation in publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate. Provide leadership in emerging novel trial designs/tools like digital twins in which the organization is heavily investing Essential Functions- Integrate strategic regulatory, statistical & drug development support services into emerging biopharmaceutical company clinical trial offerings. Interface with clients as part of the Therapeutic Science & Strategy Unit Centres of Exce