Bachelor of Arts (B.A.), Economics @
University of North Carolina at Chapel Hill
I am an experienced pharmaceutical professional with over 17 years of clinical development and project management experience in the industry. My career spans multiple therapeutic areas, phases of development and development roles. I possess excellent communication and interpersonal skills, diverse facilitation experience and a good background in project management/lean/change management techniques. I believe that embedding great project
I am an experienced pharmaceutical professional with over 17 years of clinical development and project management experience in the industry. My career spans multiple therapeutic areas, phases of development and development roles. I possess excellent communication and interpersonal skills, diverse facilitation experience and a good background in project management/lean/change management techniques. I believe that embedding great project management enables a team to be better than the sum of its parts and it allows organizations to deliver its objectives more efficiently. I am looking for the next challenging drug development assignment that will leverage my collaborative leadership style, help me grow as a professional and contribute to delivering medicines/devices/technology that will positively impact the lives of patients.
Project Director @ From March 2015 to Present (8 months) Director, Planning and Project Management @ • Lead team to build a culture of planning and discipline
• Provide project management support to programs and studies
• End to end program and clinical development planning
• Detailed study implementation and delivery planning
• Core Member, PP&M Pipeline Progression Initiative (program peer review / best practices)
• Capability development and management of direct reports
• Coach/Mentor to 4 individuals (GSK system of core PM, Change Mgmt and Lean Fundamentals)
• Facilitation of various engagements (team kick-offs, after action reviews, quality summits, etc.) From May 2010 to March 2015 (4 years 11 months) RTP, NCHead, Facilitated Clinical Review (FCR) Network @ • Led and managed network to deliver peer review to approx. 150 global protocols
• Managed a peer review network of Sr. staff focused on improving the quality of protocols
• Established and trained a local network to embed quality review in China
• Studies completing FCR averaged 44% less protocol amendments than studies that did not From November 2012 to December 2014 (2 years 2 months) Antibacterials Lead, Infectious Disease, Center for Clinical Study Excellence (CCSE) @ • Create & manage operational support strategy for antibacterial programs within the ID portfolio
• Core member of the ID Operations Leadership Team
• Line management responsibility for 8 individuals primarily working on antibacterial programs
• Represent ID CCSE on multiple critical process work streams (site identification, study feasibility) From March 2009 to June 2010 (1 year 4 months) Project Operations Manager @ • Project management accountability for program budgets and timelines
• Accountable for all vendor management associated with delivery of the program
• Direct management of the CROs utilized for global efforts
• Managed program budgets towards on-time and on-budget completion
• Managed strategic review effort to develop critical program strategic imperatives From September 2007 to June 2010 (2 years 10 months) Clinical Investigation Leader (CIL) @ • Single point of global accountability / study leadership for TOC110977
• Ensure study team is enabled to succeed in their roles and responsibilities
• Responsible for end to end delivery of study objectives and quality study data
• Primary GSK leader for outsourcing relationship with global CRO
• Primary link with GSK local operating countries for status updates From October 2007 to May 2010 (2 years 8 months) Manager, Global Clinical Operations (GCO), HIV Study Management @ • GCO Global Project Representative for strategic planning and implementation
• Study management for Phases I - IV
• Scientist on Phase I BE study in India for a Disease of the Developing World
• Global Study Manager on a Phase III HIV treatment-experienced program (5 studies, 120 sites)
• Global Study Manager on a global Phase IIIb HIV continued access trial.
• Study Manager for a 350 site, 900 subject Phase IIIb trial utilizing a novel outsourcing model From September 2001 to September 2007 (6 years 1 month) Lead CRA @ • Lead Clinical Research Associate (CRA) on 220 site, 6000+ patient Phase IIIb CV trial
• Manage internal study team relationships between PL clinical and clinical coordinating center
• Responsible for the creation and implementation of study specific Standard
Operating Procedures (SOPs)
• Management of a team of 15 CRAs From 2000 to 2001 (1 year) Project Director @ • Assumed CRA and PM management of five project teams with 3-5 team members.
• Responsible for completion of study milestones (on-time, on-budget).
• Completed the deployment of 7+ service packs to the existing MiniDoc software
• Created a new Employee Training Standard
• Wrote Regulatory Review Guidance and study closure process for MiniDoc
• Created and presented three Clinical Study Plans for potential business (2 of 3 awarded)
• Managed software development of software package for this study. From 1999 to 2000 (1 year) CRA @ • Conducted site selection, initiation, interim and close-out monitoring visits.
• Responsible for daily management of multiple sites.
• Coordinated a Ten CRA team to complete the recollection of missing data for a
study that was completed >five years prior.
• Lead Regulatory role on a Phase IV OTC Switch.
• Prepared Sponsor Reports and Presentations.
• Tracked financial line items (budgeted vs. actual) and project milestone status. From 1997 to 1999 (2 years)
MA, Exercise Physiology @ University of North Carolina at Chapel Hill From 1995 to 1997 Bachelor of Arts (B.A.), Economics @ University of North Carolina at Chapel Hill From 1990 to 1994 Heath Hair is skilled in: Clinical Operations, Clinical Trials, Pharmaceutical Industry, Clinical Development, Facilitation, CTMS, EDC, CRO, Peer Mentoring, GCP, ICH-GCP, Drug Development, Clinical Research, Clinical Monitoring, Oncology, Infectious Diseases, Therapeutic Areas, Protocol, Clinical Study Design, Clinical Data Management, Inform, Clinical Planning, Project Management
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