Marc de Somer, MD

Global clinical development leader, shifting seamlessly between strategic engineering, systematic planning and methodical execution, with proven record of delivering value and quality at significantly reduced risk, time and cost.

Clinical and statistical innovator with state-of-the-art expertise and experience in effective Phase 1 to 4 development in multiple therapeutic areas, most recently in neurology, psychiatry and pain.

Known for bringing diverse multi-disciplinary teams together in successful collaboration based on shared understanding, agreement and commitment. Experience in biotech financing, business development, partnering, as well as M&A.

CAREER HIGHLIGHTS:

► MD and EMBA degrees, master’s degrees in biostatistics, public health, and pharmaceutical medicine, plus postgraduate education in epidemiology, decision sciences, and project/portfolio management.

► Expertise in global clinical development strategy, planning, and execution, clinical trial design, data management, statistical analysis and presentation of results, for Phase 1, 2, and 3 trials, as well as Phase 4 medical affairs, drug safety and pharmacovigilance.

► Numerous successful global development and regulatory (IND/CTA-NDA/CTD) projects for small molecules and biologics, including pro-drugs and combination products, in oral, intra-nasal, and injectable formulations, in multiple therapeutic areas (neurology, psychiatry, acute and chronic pain, infectious diseases, immunology, inflammation, bone, endocrinology)

► Spearheaded special assignments and played key leadership role in biotech startups, venture fundraising and M&A.