Robin McIntosh, MBA

Premier pharma/med device development consulting

 
 

Robin improves clinical operations and reduces development timelines for pharmaceutical and medical device development.

Robin McIntosh, MBA has 30 years of experience managing the execution and implementation of complex development programs within the pharmaceutical, medical device, and biotech industries.  Robin was Vice President of Clinical Development with Recros Medica, leading clinical development and strategy for a novel aesthetic medical device.  Robin consulted with Caladrius Biosciences, working on autologous cell-based therapies for cardiovascular and Type 1 Diabetes trials.

As Director of Global Development Operations with Allergan, Inc., Robin was responsible for creating strategy and risk management for delivering fast-paced cosmetic and medical dermatology, neurology, and acute and chronic pain clinical research studies, leading to the approval of novel drugs and indications.  Robin started her career working at Chiron Vision Corporation (a former subsidiary of Chiron Corporation) managing ophthalmic refractive surgery clinical studies. 

Additionally, Robin is an instructor with UCI’s Division of Continuing Education. Robin holds a Bachelor of Science degree in Biology from Washington and Lee University, and a Master in Business Administration (MBA) degree from Pepperdine University Graziadio School of Business and Management.

Expertise

 

Clinical Development and Operations

Robin works with clients to develop clinical strategy, research indications, write key documents, and manage operational components of clinical studies. 

  • Contribute to and create documents for NDA, BLA/IND, response to FDA questions

  • Budget planning, forecasting, and management

  • Early strategic clinical planning

  • Reduce clinical development timelines

  • Ensure inter-departmental alignment of development plan with preferred label/marketing claims

  • Preemptive risk management planning

  • Site training designed for maximum impact to primary efficacy variable and low incidence of non-evaluable subjects

  • Clinical staff recruitment and development

  • Build long-term relationships with vendors and sites