placeholderLEADERSHIP / CLINICAL DEVELOPMENT

PERSONAL PROFILE

  • 29 years in drug development.

EXPERTISE

CMO, Operational Oversight, Strategic Planning & Development, Clinical Development and Medical Oversight, Negotiating and Influencing, Team Leader, Line Manager, Team-Building, and Engagement.

PROFESSIONAL EXPERIENCE

Pharmaceutical Consultant, Harrigan Consulting, LLC
Strategic review partner for venture investors in drug development. Subject matter expert for clinical development, regulatory environment, and medical issues. Reviewer of numerous clinical development plans to advise on benefit/risk, challenges to implementation, and likelihood of regulatory success. Collaborate with innovator companies to discuss compounds and to review clinical and regulatory plans.

Head, Worldwide Development Operations, Senior Vice President, Pfizer, Inc.
Provided leadership, strategic direction, and administration of Global Development Operations functions including Clinical Study Start-Up, Management and Monitoring, Data Management Services, Contracts and Outsourcing, Clinical Programming and Writing, SOPs, and Training and Processes for all clinical studies from Phase 1 (healthy volunteers) through Phase 4 (post-marketing) for multiple therapy areas. Provided oversight of three Phase 1 Clinical Research Units, China Research and Development unit, and country clinical operations staff: 1200 clinical studies, 1400 internal staff, >6000 contractors, and annual budget of $800-$1.2B. Maintained quality, timeliness, and budget, managing within 1% of line budget. Spearheaded efforts to minimize risk by incorporating quality control into all activities and liaised with partnering lines including legal and clinical staff. Successful merger activities: absorbed clinical operations staff from Wyeth while maintaining performance on existing studies and revised Development Operations line to support new Business Unit model. Championed Lean Six Sigma continuous improvement effort to reduce time of clinical trial conduct, halving number of country offices, overhauling site selection process, reducing protocol amendments, and optimizing development plans. Received Pfizer Achievement Award for these efforts. Initiated expansion of China clinical operations into new site at Wuhan. Expanded Phase 1 Clinical Unit activities into targeted Phase 2a areas in support of specific Business Unit needs. Reduced time to produce tables, study reports, and publications. High scores on Gallup Survey of employee engagement conducted to assess manager/leader capabilities.

Global Team Leader, Vice President of Clinical Development, Pfizer, Inc.
Global Team Leader for late-stage clinical drug development products, including compounds for schizophrenia, oncology, and osteoporosis. Directly supervised clinicians and extended teams, accountable for project delivery and future development plans. Key presenter at multiple global regulatory meetings within US, Europe, and Asia. Strategically directed the selection and recruitment of all clinical team colleagues globally. Designed and presented Clinical Development Program to Senior Management and Board Members. Main presenter for successful antipsychotic intramuscular formulation at public FDA Advisory Committee Meeting. Led first Pfizer late-stage clinical product through simultaneous Japanese development. Reputation for delivering clinical program goals and motivating top talent. Extensive partnership with marketing and other key stakeholders on development plans. Initiated forum for Team Leaders to establish and share common practices and mentored new leaders.

Head of Clinical Oncology Group, Director of Clinical Development, Pfizer, Inc.

Established group, supervising four clinicians and a business manager. Responsible for all clinical oncology studies: delivery of Phase 2 compound to successful Proof of Concept, recruitment of high-caliber clinicians, resolution of legacy performance issues, team-building, and strategic review of oncology portfolio.