Switzerland
Drug development leader and visionary innovator with strong track record of successful early and late development programs and regulatory approvals, with exceptional ability to build and lead high-performing teams and manage cross-functional and departmental complexity.
Operating as a strategic leader and senior developer at the asset team and cross-company leadership level. Directing and managing through influence over 11 different indication teams in therapeutic areas of neuromuscular, endocrinology, hematology, rheumatology/immunology and rare diseases. Ensuring top quality innovative clinical programs are conceived, delivered and executed to build out the full potential of the asset and company’s long term ambition vision. Driving alignment, innovation, differentiation, for first-/ best-in-class FcRni across a variety of indications. Growing sustainably the internal pipeline and next-generation opportunities, along with prioritizing new indications through external collaborations, partnerships, BD assessments. Actively shaping the structure and building the growing biotech organization. Attracting/developing key talent, with focus on leadership and strategic expertise and excellence. Representing argenx broadly to internal/external key stakeholders and partners. Standing member of the Development Leadership Team and Development Management Committee. Deputy to the CMO.
Responsible for a broad immunology portfolio in line with clinical excellence, acceleration and asset/ indication prioritization. Attracting, recruiting, developing strong talent, while managing an international clinical immunology group. Establishing and leading a newly formed clinical group at the Swiss innovation hub site. Member of the Boudry site leadership team, representing global drug development function. Collaborating with cell therapy franchise through concept, development and expansion of CART therapy and TCEs in the field of lupus, autoimmune and rare diseases. Industry Co-Chair for the Lupus Accelerating Breakthroughs Consortium (public-private partnership) consortium.
Leading the clinical development of multiple assets across a variety of immunologic indications. Creating and communicating a vision for designing and implementing innovative development plans. Setting differentiated strategies and executing on global development and registrational plans. Supervising directly the work of clinical development leads and trial physicians.
Led clinical teams in all aspects of strategy and execution of two new development programs for lupus (Phase 2b) and ankylosing spondylitis (Phase 2a). Formulated the global strategy, defined the TPP, prepared and executed the integrated development plan. Represented the clinical line function on project and program levels and internal management boards. Responsible for interactions with Health Authorities, Ethics Committees and IRBs. Led the DMC/DSMB, Steering Committee and Advisory Board meetings. Developed and maintained ongoing relationships with key scientific experts and consultants. Contributed to lifecycle management plan of assets in development across different autoimmune indications.
Responsible for the execution of a large Phase 3/ 3b psoriatic arthritis clinical development program with apremilast (PALACE). Additional autoimmune indications included psoriasis, ankylosing spondylitis, rheumatoid arthritis, Behcet’s disease. Managed critical aspects of planning, start-up, conduct and oversight of pivotal studies. Responsible for close-out activities of 5 clinical studies – comprehensive data review and analysis, CSR writing, publication planning and execution, label updates. Supported Health Authority submissions and responses. Provided scientific and medical input for global strategy, data analysis, reporting and presentations at key rheumatology meetings and congresses. Collaborated with the Medical Affairs team on pre- and post-launch activities, RML/MSL training, lifecycle management, scientific publications, IITs review and approvals.
Involved in a large global clinical development program (Phase 2-3) for monoclonal antibody development across multiple indications (Psor, PSA, RA, AS) that led to the approval of a first in class IL-17A inhibitor (Cosentyx). Completed a Global Program Medical Director program in the areas of clinical development, drug safety and epidemiology, regulatory and medical affairs.
Assisted in the conduct of Phase 1/2 clinical studies at the Parexel early phase clinical unit in multiple therapeutic areas: cardiovascular, endocrinology and metabolism, GI, pulmonary, immunology, CNS and vaccines.