Experience

HighTide Therapeutics
• China
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Chief Development Officer

  • Feb 2021 - Present

Alchemeos Clinical Consulting LLC
• Principal

  • Jan 2021 - Present


Intercept Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• • Jun 2013 - Jan 2021

  Global drug development professional with a robust history of success as a key contributor in the design and execution of clinical drug programs for regulatory approvals and labeling updates across multiple therapeutic areas, including metabolic and liver diseases. Serve as an expert and leader in devising and implementing trials for all phases of development and guiding informed strategic business decisions. Accountable to the Chief Medical Officer to lead the design and execution of clinical development programs, directing and/or providing broad medical input to all activities required to conduct and monitor multiple clinical trials; Activities include protocol planning, through execution and the preparation of study reports, manuscripts and regulatory NDA and MAA filings. Integrate pharmacokinetics, biomarkers, biostatistics, drug safety and regulatory strategy into the creation and revision of clinical development strategic plans. Clinical lead for CTD submissions and regulatory responses, providing scientific expertise, high level strategic planning and project oversight of such regulatory submissions and regulatory interactions. Provide clinical and strategic support to evaluation of life-cycle opportunities. Line management of other clinical development staff including Clinical Science, Clinical Pharmacology/DMPK, Medical Writing, Health Economics Outcomes Research and Biostatistics. Show less

• • Jun 2013 - Mar 2014



Amylin Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Director, Medical Research and Development

  • Feb 2003 - Jun 2013

  Provide broad scientific and medical leadership to activities that span the scope of medical research and development. Lead the development of short- and long-term clinical research planning strategies. Participate at a high level in all aspects of clinical development and study management, providing leadership, scientific expertise and logistical support to cross-functional project teams to ensure aligned clinical development strategies are fully implemented; translate strategic needs into specific objectives for teams and personnel to pursue. Apply therapeutic area expertise in the successful design of complex clinical trials. Provide high level oversight of cross-functional project teams for NDA submissions and regulatory responses, contributing scientific expertise and strategic oversight of regulatory submissions and regulatory interactions. Provide input to and participate in cross-functional initiatives including product labeling, IND/NDA annual reports, PSURs/PADERs, clinical study reports. Line management role for high-functioning medical research department; Mentorship of scientists supporting multiple Clinical Development and Medical Affairs projects; assist in setting organization structure and manage personnel activities; manage personnel activities such as delivering performance reviews, establishing development plans for staff, ensure resource distribution across projects, lead disciplinary actions. Show less



The Salk Insitute for Biological Studies

• Postdoctoral Scientist

  • 1998 - 2003

  Research: Examined the expression, regulation, and action of novel TGF-beta system molecules in modulation of the hypothalamic-pituitary axis. Research: Examined the expression, regulation, and action of novel TGF-beta system molecules in modulation of the hypothalamic-pituitary axis.



University of California

• United States
• Higher Education
• 700 & Above Employee

• Research Technician

  • Jan 1989 - Jan 1992

  Examine the role of dopamine elements in opiate reinforcement. Examine the role of dopamine elements in opiate reinforcement.