Executive Medical Director, Clinical Program Lead, Immunology / Rheumatology

Acts as medical expert and leader in interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards Uses excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions; uses that creativity and knowledge to build and defend data-driven plans and decisions, both with internal scientific management and the Company's partners/collaborators Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape; designs and develops smaller, yet robust and innovative FIH as well as Phase 2/3 programs Drives strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making; leads dynamic and matrixed clinical teams in a fast-paced and hands-on environment Leads and develops a team of MDs and clinical scientists to meet business needs Requirements An advanced degree in medicine (MD or equivalent) required; Specialized fellowship training in Immunology or Rheumatology preferred. A minimum of 6-8 years of industry experience in related therapeutic area clinical development is preferred Demonstrated consistent track record in a range of leadership roles, including working with senior clinical development staff and establishing credibility with external collaborators such as opinion leaders and regulators Substantial experience in drug development, including experience with both IND and BLA/NDA submission Experience leading study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, and handling health authority responses A strong commitment to impacting patients through drug development and the ability to work well within a team setting. People management experience is a plus Core Competencies Demonstrates expertise in clinical development with a focus on innovative strategies for drug development, including IND and BLA/NDA submissions. Proven leadership in managing multi-disciplinary teams and building consensus among internal and external stakeholders. Highest-signal resume keywords Advanced Degree In Medicine (MD) Clinical Development Leadership Drug Development Experience IND And BLA/NDA Submission Team Management ATS Optimization Keywords Hard Skills Clinical Strategy Development Phase 1/2/3 Program Design Data-Driven Decision Making Medical Review Database Lock Management Soft Skills Consensus-Building Creative Problem Solving Collaboration Communication Certifications & Qualifications Specialized Fellowship Training In Immunology Or Rheumatology Industry Keywords Regulatory Authorities Key Opinion Leaders Advisory Boards Patient Advocacy Groups Health Authority Responses #J-18808-Ljbffr Jobtailor