Executive Medical Director, Clinical Development- Immunology

Committed to advancing breakthrough treatments for patients with immune-mediated diseases, Vertex is building the clinical organization to match its scientific ambition in immunology. We are seeking a physician-scientist with a comprehensive understanding of molecular pathways as drivers of inflammatory and autoimmune diseases across a range of organs — and of the investigative treatment landscape targeting those pathways — to help shape Vertex's immunology portfolio beyond existing programs.   Povetacicept, our lead immunology asset, is a differentiated TACI-Fc fusion protein that dually inhibits BAFF and APRIL, now advancing into a broad portfolio of antibody-mediated autoimmune indications with compelling early signals. As  Executive Medical Director, Clinical Development , you will serve as Vertex's primary physician voice on the povetacicept franchise in immunology while contributing your scientific perspective to how Vertex thinks about immunology more broadly about which programs to advance, which mechanisms to pursue, and how to position Vertex as a credible, durable force in a field that is moving fast.    This role operates at the intersection of Research, Regulatory, Medical Affairs, Global Patient Safety, Clinical Operations, Commercial, Pharmaceutical Development and Business Development.

Requires comprehensive understanding of the drug development process extending from Phase 1 to Phase 4 Is a recognized and respected authority in the immunology or rheumatology field Has experience overseeing clinical development programs and managing their design and implementation by providing project team leadership  Participating in the planning and execution of global clinical development activities including setting up data monitoring committees, steering committees, and investigator meetings  Representing the clinical development team at cross-functional meetings  Develop study protocols  Reviewing Investigator Brochures  Reviewing and evaluating study subject exemptions  Overseeing medical monitoring of clinical studies  Assisting medical monitors in evaluating adverse events and safety profiles  Participating in data reviews  Participating in the development of briefing books and preparing the team for regulatory interactions   Interfacing with international regulatory authorities to support development objectives  Ensuring compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirements  As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.  Knowledge and Skills: Experience   interacting with global regulatory agencies   including EMA, Health Canda, TGA, PMDA and CDE   Possess   a   working   knowledge   of   biostatistics,   data   management,   clinical   operations   and clinical pharmaco logy   Experience   in   filing   and   defending   US   INDs   and/or   NDAs   and/or   their   international   equivalents   Ability   to   work   in   a fast-paced and   ambigu ous environment ,   and willing to provide   hands - on   assistance   when needed to junior staff   to help teams meet their goals   Ability   to   function effectively in a   team-based   matrix   environment   Ability   to   work   independently   to   resolve   challenges   and   conflicts   Excellent computer skills includ ing   familiarity   using   AI -based   large language models   to solve   problems    Excellent   oral   and   written   communication   Excellent   leadership   skills   Education and Experience: 15   years   pharmaceutical   industry   experience,   including   time   designing and overseeing