- > 25 years in pharma industry, building top-tier global teams that consistently achieved strategic and financial objectives. Strong leader with the ability to create a global vision, effectively allocate resources, and customize/operationalize regional medical strategies that support business growth.
- > 10 years (prior to industry) in clinical/academic neurology practice.
Medical Executive/Chief Medical Officer with experience spanning Global R&D and Commercial Strategy and Operations (Europe, Asia-Pacific, Latin America), In/Out Licensing, M&A Strategy/Due Diligence, Clinical Study Design, Pharmaceutical Development (all phases), Alliance-based Product Development, Regulatory Compliance, Global New Product Launches, Corporate Team-building, Leadership and Management.
MD and MBA from Columbia University, New York, NY.
Interim Chief Medical Officer and Senior Vice President, The Medicines Company
Created and implemented an organizational structure and compliant processes and procedures for medical input to marketing team. Led departments including Medical Affairs, Clinical Operations, Data Management, Biostatistics, Programming, Clinical Pharmacology, and Nonclinical Toxicology.
Interim Chief Medical Officer, Sage Pharmaceuticals
Finalized Target Product Profile (TPP) and developed Clinical Development Plan (CDP) for compound to treat status epilepticus (SE). Developed and submitted SE IND, determined nonclinical work to support IND, and designed protocols for first studies. Completion of studies led to successful IPO. Developed CDPs for the Anesthesia and Fragile X programs. Helped recruit permanent CMO. Advised company on portfolio compounds to be developed and created development plans.
Consultant, Forest Laboratories, Inc.
Created “user-friendly” improvements to company’s promotional review process. Developed processes to improve quality and comply with the Corporate Integrity Agreement with the US Department of Justice.
Interim Chief Medical Officer / Interim Medical Compliance Officer, Savient Pharmaceuticals, Inc.
Managed staff and led process to implement all medical/clinical post-marketing agreements with the FDA (protocols, periodic safety updates, etc.). Created and submitted Orphan Drug Application and a Marketing Authorization Application to the European Medicines Agency, leading to approval to market Krystexxa® (pegloticase). Assessed, hired, and managed CROs to assist in the submission of the ODA and MAA and to perform the pharmacovigilance activity in the US and Europe. Created and instituted SOPs for medical science liaisons and promotional materials review committee. Part of corporate management team.
Vice President, Global Medical Affairs, Wyeth Pharmaceuticals
Responsible for therapeutic areas including CNS, Hematology, Oncology, Women‘s Health, Musculoskeletal/Inflammatory, and GI/Metabolism. Successfully managed negative impacts of crises, including eliminating “Urgent Safety Restriction” imposed by UK and managing negative impact on product by NIH’s Women’s Health Initiative. Created and instituted global crisis management team. Helped grow Enbrel’s sales to $5B with strategic plans addressing KOL concerns. Part of Copy Clearance Executive Committee to create advertising that was medically accurate and in legal and corporate compliance. Regional Medical Director for Latin America and Asia-Pacific, helping grow LA sales from $400MM to $1B over 4 years and increasing AP drug development, approvals, and sales opportunities.