Microsoft word - groves resume 3-1

LESLEY GROVES, PhD
(415) 715-8570 Office
(415) 933-0392 Cell
[email protected]
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 Skil ed in study design and data analysis; general clinical operations; management of projects, Experienced medical writer of regulatory documents, study-related materials, manuscripts, posters, Excel ent oral and written communication skil s, computer expertise PROFESSIONAL EXPERIENCE

Groves Pharma Consulting – Brisbane, CA
2010 – present
Principal
Independent consultant to pharmaceutical and biotech companies in the areas of clinical development, operations and medical writing Affymax Pharmaceuticals, Inc – Palo Alto, CA
2008 – 2010
Senior Director, Clinical Operations

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

Specific Accomplishments
Managed clinical department (30 ful -time employees and contractors) to achieve on-time completion of Phase III enrol ment (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 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 LESLEY GROVES, PhD
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 Col aborated with Regulatory Operations to implement and populate eFiles (Livelink) and Updated existing SOPs to more accurately reflect existing procedures and meet GCP standards; wrote 10 additional, required SOPs
Peplin, Inc – Emeryville, CA
2007 – 2008
Senior Director, Project Management

Responsible for developing and managing overal 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 Cal -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,
Santarus, Inc – San Diego, CA
2005 – 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 al projects Provided al study estimates for department budgets and managed budgets 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 LESLEY GROVES, PhD
Ligand Pharmaceuticals, Inc - San Diego, CA
2004 – 2005
Senior Director, Clinical Operations
Reconstituted the Clinical Operations Department at Ligand. Managed 27 employees al ocated among four groups: Medical Writing; Clinical Documents and Central Records Management; Finance, Contracts and Outsourcing Management; Training, Development and Clinical QC Specific Accomplishments
Instituted new employee orientation program and drug development seminars for Clinical Redesigned RFP, contracting, and payment procedures to simplify and improve accounting Reestablished Medical Writing Group; coordinated with Regulatory Department to develop process for document creation and management using Documentum and publishing using Spearheaded hiring initiative and decision process to hire 25 new employees in 7 months Reconvened the SOP committee to review and rewrite outdated SOPs; 50% of task
Élan Pharmaceuticals, Inc - San Diego, CA
1993 – 2003
Senior Director, Clinical Operations
2002 - 2003
Created and managed Clinical Operations Department at Élan, consisting of 15 employees al ocated among four groups: Medical Writing, Clinical Informatics, Finance, Contracts and Outsourcing Management, and Training and Development Managed the FDA review process for Zelapar NDA submitted 4/02. “Approvable” letter 2003.
Specific Accomplishments
Responsible for complete rewrite and synthesis of multiple clinical SOPs into one cohesive Transferred al medical writing for Antegren CTD from CRO to “in-house” medical writers Defined user standards and templates for new instal ations of Documentum and Core Established Master Service Agreement and Preferred Provider Selection procedures Completed contracts to replace 20 LOIs that had been in effect for as long as 4 years Consolidated 16 individual contracts with laboratory vendor into one MSA with price Redesigned process for invoice payment and tracking to achieve payment within contract specifications while reducing staff from five to two employees Developed a clinical trial management database in Access for use by al departments Upgraded financial database to provide more meaningful reports and access to the system Created Clinical Operations information and reference intranet web page Col aborated with Regulatory Affairs to consolidate and reorganize central file storage in San Diego. Redesigned system to streamline and prepare for transition to electronic files Initiated educational program: basic drug development, science and project overviews LESLEY GROVES, PhD

Director, Clinical Research
1999 - 2002
Associate Director, Clinical Research
1996 - 1999
Clinical Scientist, Clinical Research
1993 - 1996
As a member of the project teams, contributed to the fol owing development projects: • Zanaflex® (tizanidine HCI, immediate release) - NDA approved 1995 Designed and supervised pivotal trial. Edited, QC’d study reports, NDA components. Prepared responses to FDA questions. Wrote manuscripts, posters, presentations Diastat® (diazepam rectal gel) - NDA approved 1997 Designed and supervised pivotal trials. Edited, QC’d study reports, NDA components. Prepared responses to FDA questions. Wrote manuscripts, posters, presentations Zonegran® (zonisamide) - wrote clinical development plan for pediatric indication Tizanidine MR - designed and implemented Phase Il program Myobloc® - designed and implemented program for second indication Solvay Pharmaceuticals - Marietta, GA
1990 - 1993
Senior Clinical Research Associate, Central Nervous System
Luvox® (fluvoxamine) - NDA approved 1994 Wrote, edited and QC’d patient narratives and sections of the ISS, which summarized a 37,000 patient database; coordinated medical review of 1,000+ EKGs and writing of Monitored long-term, open-label safety study Abbott Laboratories - Chicago, IL
1988 - 1990
Clinical Research Associate, Central Nervous System
Prosom® (estazolam) - Worked with team to complete additional safety studies and responses to FDA leading to NDA approval Depakote® (sodium valproate) - Wrote protocol and initiated first pivotal trial for Bipolar Initiated, monitored and closed out safety and marketing studies for Prosom
Rush-Presbyterian-St Luke’s Medical Center - Chicago, IL
1984 - 1988
Director of Geropsychiatric Research, Department of Psychiatry
EDUCATION
American Medical Writers Association (AMWA) Certification – in process Coursework to Date: Basic Grammar and Usage I and II Statistics for Medical Writers and Editors Introduction to Writing Clinical Study Reports PhD, Clinical Psychology/Gerontology - Northwestern University, Chicago, IL MS, Counseling Psychology - Il inois Institute of Technology, Chicago, IL BA, Psychology - Wilson Col ege, Chambersburg, PA LESLEY GROVES, PhD
PUBLICATIONS
1 Brown L; Bergen DC; Kotagal P; Groves L; Carson D. Safety of Diastat(R) when given at larger-than-recommended doses for treatment of acute repetitive seizures. Neurology 2 Groves L; Shel enberger MK; Germanson TP; Carson D; Haney CD. Diastat(R) (diazepam rectal gel): One dose or two? Epilepsia 1999 40(7) 93 3 Groves L; Shel enberger MK; Wal ace JD; Hil JM. Zanaflex(R) dosing: Patient assessment of benefit at escalating doses. Neurology 1999 52 (6 Suppl 2) A134 4 Mitchel WG; Conry JA; Crumrine PK; Kriel RL; Cereghino JJ; Groves L; Rosenfeld WE. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: Safety, efficacy, and tolerance. Epilepsia 5 Shel enberger MK; Groves L; Shah J; Novack GD. A control ed pharmacokinetic evaluation of tizanidine and baclofen at steady state. Drug Metab Dispos 1999 27(2) 6 Groves L; Shel enberger MK; Davis CS. Tizanidine treatment of spasticity: A meta- analysis of control ed, double blind, comparative studies with baclofen and diazepam. 7 Groves L; Wal ace J; Shel enberger K. Effect of cimetidine on zonisamide pharmacokinetics in healthy volunteers. Epilepsia 1998 39(Suppl 6) 191 8 Mitchel W; Crumrine P; Conry J; Groves L and the North American Diastat Study Group. Long-term study of Diastat (diazepam rectal gel) for management of episodes of acute, repetitive seizures in patients with refractory epilepsy. Neurology 1998 50(4 9 Mitchel WG; Groves L; Conry JA; Crumrine P. Rectal diazepam gel (Diastat) for breakthrough seizures: Long-term, repeated use. Epilepsia 1998 39(Suppl 6) 50 10 Shel enberger K; Groves L; Franklin J; Carson D. Diazepam rectal gel (Diastat) therapy of acute epileptic seizures does not compromise respiratory function. Annals of 11 Shel enberger K; Wal ace J; Groves L. Effect of food on pharmacokinetics of zonisamide in healthy volunteers. Epilepsia 1998 39(Suppl 6) 191 12 Stazio A; Groves L; Hudson S. Zanaflex treatment of spasticity in patients with multiple sclerosis: A long-term, open-label study. Neurology 1998 50(4 Suppl 4) A147 13 Wal ace J; Shel enberger K; Groves L. Pharmacokinetics of zonisamide in young and elderly subjects. Epilepsia 1998 39(Suppl 6) 190 14 Groves L; Carson D; Franklin J; Santil i N. Long-term study of Diastat (Diazepam Rectal Gel) for management of episodes of increased seizure activity in patients with refractory LESLEY GROVES, PhD
15 Shel enberger K; Groves L; Franklin J; Carson D. Diastat (Diazepam Rectal Gel) therapy of acute epileptic seizures does not compromise respiratory function. Epilepsia 16 Groves L; Shel enberger K; Franklin J; US Diastat Safety Study Group. Safety and tolerability of a single dose administration of Diastat (diazepam rectal gel) to patients with epilepsy on antiepileptic drugs (AEDs). Epilepsia 1996 37(Suppl 5) 154 17 Mitchel WG; Shel enberger K; Groves L; Cereghino J; Murphy J; Rosenfeld W; Farwel JR. Rectal diazepam gel (Diastat) for acute repetitive seizures: Results of a double blind, placebo-control ed study in children and adults with epilepsy. Epilepsia 1996 18 Lataste X; Emre M; Davis C; Groves L. Comparative profile of tizanidine in the management of spasticity. Neurology 1994 44(11 Suppl 9) S53 19 Lazarus LW; Winemil er DR; Lingam VR; Neyman I; Hartman C; Abassian M; Kartan U; Groves L; Fawcett J. Efficacy and side effects of methylphenidate for poststroke depression. J Clin Psychiatry 1992 53(12) 447 20 Pierce MW; Shu VS; Groves LJ. Safety of estazolam. The United States clinical 21 Cohler BJ; Groves L; Borden W; Lazarus L. Caring for family members with Alzheimer's disease. In Light E; Lebowitz BD (Eds); et al. Alzheimer's Disease Treatment and Family Stress: Directions for Research. 1989 50 22 Groves LJ. Psychological distress of caregivers to spouses with Alzheimer's disease. (Northwestern University, Chicago, IL, USA) Dissertation Abstracts International, 1989 23 Lingam VR; Lazarus LW; Groves L; Oh SH. Methylphenidate in treating poststroke depression. J Clin Psychiatry 1988 49(4) 151 24 Gierl B; Groves L; Lazarus LW. Use of the dexamethasone suppression test with depressed and demented elderly. J Am Geriatr Soc 1987 35(2) 115 25 Lazarus L W; Groves L. Brief Psychotherapy with the Elderly: A Study of Process and Outcome. In Sadovoy J and M Leszcz (Ed). Treating the Elderly with Psychotherapy: The Scope for Change in Later Life. International Universities; Madison CT 1987 265 26 Frankel R; Groves L; Gierl B. A case for reminiscence group therapy on geropsychiatric hospital units. Gerontologist 1986 26 A210 27 Lazarus LW; Groves L; Gierl B; Pandey G; Javaid JI; Lesser J; Ha YS; Davis J. Efficacy of phenelzine in geriatric depression. Biol Psychiatry 1986 21(7) 699 28 Newton N; Schneider A; Lazarus L; Groves L; Del efield K. Relation between psychiatric treatment and cognitive functioning in elderly depressed patients. Gerontologist 1982 22

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