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Experience
Consulting in Drug Development / Medical Affairs / Business Development
Advised clients on all aspects of medical affairs, from strategic planning and collaboration with commercial counterparts, to tactical implementation, metrics development, and performance assessment. Created scientific narratives for complex topics, such as novel mechanisms of action or applications of artificial intelligence. Supported business development. Developed and reviewed regulatory documents, designed drug development programs. Provided clinical and regulatory insights for using machine learning and historical databases to enhance the efficiency of clinical trials.
Vice President, Therapeutic Area Head, Neuroscience
Defined strategic direction for a portfolio of pain medicines including Lyrica, Dynastat, abuse-deterrent opioids, and compounds in development for pain and neurological disorders. Provided medical and clinical perspective for Business Development candidates' review and decisions. Lead the team through approval and launch of two novel agonist/antagonist abuse-deterrent opioids, delivered large operating plans on time and on budget.
Executive Director, Disease Area Lead, Pain
Managed a broad portfolio of analgesic medicines (as above, plus Celebrex and Flector Patch). Worked with multiple internal and external experts to develop an internally consistent and externally transparent cross-Pfizer therapeutic area strategy in support of appropriate assessment and management of patients with chronic pain.
Executive Director, Team Leader
Lead teams of scientists and physicians providing medical affairs expertise and leadership for major Pfizer brands including Chantix for smoking cessation. Lead the development of an 8,000-patient neuropsychiatric safety study of Chantix and competitors, negotiated protocol with the FDA, and set up an inter-company collaboration; the outcome of the study served as the basis for an unprecedented removal of boxed warning from the Chantix label.
Team Leader
Designed and implemented Phase 2/3 development programs in genitourinary & gastrointestinal therapeutic areas. Responsibilities included Business Development and Licensing evaluations in multiple therapeutic areas and with a global focus, in New York and in Tokyo, Japan, as well as the support of pre-launch planning for internal products in late-stage clinical development.