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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Groves, Lesley, PhD
Business Name Groves Pharma Consulting
Certifications
Education

American Medical Writers Association (AMWA) Certification – in process

PhD, Clinical Psychology/Gerontology - Northwestern University, Chicago, IL

MS, Counseling Psychology - Illinois Institute of Technology, Chicago, IL

BA, Psychology - Wilson College, Chambersburg, PA

Business Address 529 Visitacion Avenue
Brisbane, CA 94005
USA
Contact information
Telephone:
Mobile Number:
Email address:
415-85909764
415-933-0392
lesley@grovespharma.com
Specialties

PhD-prepared professional with 20+ years experience in pharmaceutical development and 5 years experience coordinating hospital-based clinical research

Significant contributor to nine development programs and four NDAs

Skilled in study design and data analysis; general clinical operations; management of projects, studies, CROs, and employees

Experienced medical writer of regulatory documents, study-related materials, manuscripts, posters, and PowerPoint presentations

Excellent oral and written communication skills, computer expertise

Experience

Groves Pharma Consulting - Brisbane, CA                                                                      5/2010-present

Principal

Independent consultant to pharmaceutical and biotech companies in the areas of clinical development, operations and medical writing, including regulatory submissions, SOPs, posters, manuscripts and other medical information documents

Affymax Pharmaceuticals, Inc - Palo Alto, CA                                                                            8/2008-4/2010

Senior Director, Clinical Operations

 Responsible for completion of Phase II and management of ongoing Phase III Hematide clinical development programs

Specific Accomplishments

  • Managed clinical department (30 full-time employees and contractors) to achieve on-time completion of Phase III enrollment (4 studies; 2600+ patients)
  • Planned and conducted one US and one international Study Coordinator meetings to refresh protocol knowledge and update study procedures
  • Obtained additional funding and support for doubling monitoring resources to eliminate monitoring backlog
  • Initiated targeted data review by internal CRAs and contractors to identify and correct data anomalies not identified by CRO data management
  • Produced monthly Study Newsletters; IB updates; 4 Phase II CSRs; 4 Phase III protocol amendments; 3 revisions to Pharmacy, Monitoring, and Data Handling Manuals
  • Initiated and completed transition of 4 Phase III studies to new IRB in one month; required that 80 sites be reapproved by new IRB and approximately 2000 patients be re-consented
  • Collaborated with Regulatory Operations to implement and populate eFiles (Livelink) and train personnel in its use
  • Updated existing SOPs to more accurately reflect existing procedures and meet GCP standards; wrote 10 additional, required SOPs

Peplin, Inc - Emeryville, CA                                                                                                             8/2007-6/2008

Senior Director, Project Management

Responsible for developing and managing overall project plan, budget and timeline for Phase III program leading to NDA to be filed for NCE for treatment of skin cancer

Specific Accomplishments

  • Created project timelines with multiple methods for presentation (Microsoft Project, Excel, Power Point and Visio) to line staff, upper management, company board, and investors
  • Completed 3 backlogged clinical study reports for NDA filing
  • Developed and managed Medical Information, including Scientific Advisory Board meeting, Exhibitor Booth at dermatology meetings, and Call-In Center for medical inquiries
  • Contributed to regulatory submissions as author or editor, including US and Australian regulatory briefing documents, investigator brochures, protocols, statistical analysis plans, annual reports

Santarus, Inc - San Diego, CA                                                                                                            3/2005-7/2007

Senior Director, Clinical Operations

Responsible for policy, procedure and system improvement and maintenance for Department of Clinical Research and Medical Affairs.  Includes developing and managing budgets and timelines; contracting and outsourcing; CRO selection, supervision and evaluation; writing and updating SOPs, department education and training; clinical development plans, protocol design, study implementation and management; regulatory filings; data reviews and clinical study report writing; producing and editing publications, presentations and posters

Specific Accomplishments

  • Developed and implemented detailed Microsoft Project timelines for all projects
  • Produced all IND and NDA Annual Reports
  • Provided all study estimates for department budgets and managed budgets
  • Negotiated all clinical contracts
  • Revised and updated all SOPs
  • Managed and completed 4 PK/PD patient dosing trials on time and under budget
  • Supervised completion of 8 outstanding clinical trial reports
  • Clinical representative to investigator-initiated research grant and new product development committees
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