Joan A.

Sutphen
203 River Edge Drive
Point Pleasant, NJ 08742
908.770.9026
jsf04292@westpost.net
Executive Summary:
Multiple years of project management and operational management have
molded me into a strong leader of departments and teams. With
experience in both CRO and pharmaceutical/biotech worlds I have
developed strong negotiations skills and am well versed in managing
the CRO/Sponsor relationship and the inherent difficulties that evolve
around time, quality and costs. I have been the first US employee in a
French-based company and have led a small clinical team to facilitate
completion of several large clinical studies. I have successfully
directed organizational changes that were not always popular. In a
nutshell - I get the job done.

Experience:
NicOx Sophia Antipolis, France
Director, US Clinical Operations 2007 to 2010
Overall responsibility for clinical operations in the United States
including, but not limited to Clinical Project Management for US
portions of one global Phase 3 clinical study and for 6 Phase 1 to 3
stand-alone US clinical studies
Participated in development of all RFPs and Task Orders for clinical
projects conducted globally or stand-alone US. Assisted legal
department with negotiation and finalization of 2 Master Service
Agreements
Managed CROs/CRAs/CPMs adherence to agreed recruitment plan,
timetables, budget and quality specifications, ensuring overall
quality performance of the CRO and study sites. Acted as Clinical
Project Manager on 2 clinical studies when necessary due to corporate
needs

Participated in development and review of four study specific

Clinical Study Reports, annual regulatory reports, and clinical
documents supporting NDA
Facilitated communication/interaction with US based vendors other
than CROs to assure quality performance and responsiveness to project
team needs
Line management responsibility for US based clinical personnel
including managing information flow/communication to ensure smooth
running of projects and that employees are kept informed of global
NicOx information
Managed resources to ensure optimal utilization of US based staff
 Prepared and/or reviewed NicOx Clinical Standard Operating
Procedures. Checked that sub-contractor CRO SOPs met NicOx' basic
requirements
Represented NicOx when dealing with US based external vendors or
partners in an ambassadorial role, including facilitation of
collaboration with US Key Opinion Leaders in the relevant therapeutic
areas
Performed as Project Leader on additional corporate initiatives as
defined by management, including preparation for Joint FDA/EMA
Inspection and Establishing Post Marketing Call Center
Premier Research Group (formerly SCIREX) Philadelphia, PA
Senior Director, Clinical Monitoring Services 2006 to 2007
Was instrumental in development of the Clinical Monitoring Services
group in which the managers provided line supervision of monitors and
career guidance and assistance to monitors, along with assessment and
resolution of unique issues affecting home-based monitors

Was responsible for the supervision of personnel in, and development

and implementation of the programs managed by the Clinical Monitoring
Services group.
Served as liaison between Clinical Trial Management and the Clinical
Monitoring Services group
Planned, developed, revised and implemented programs managed by the
Clinical Monitoring Services group
Oversaw revision and implementation of New Hire Orientation for
monitors
Oversaw revision and implementation of Monitoring Assessment program
Served as a resource to assigned staff if remedial training or
action plans were necessary for their direct reports
Ensured optimal utilization of all clinical monitors
Planned and managed the growth of Clinical Monitoring Services,
including recruitment and training of eight direct reports

Assisted in the development and revision of departmental policy

Managed Clinical Monitoring Services metrics
Served as a resource for Clinical Monitoring Services staffing
allocations and assignments
PRA International Eatontown, NJ
Project Director 2005 to 2006
Oversaw management of clinical trials, assisted in scheduling and
tracking of study activities, provided monthly reports to clients on
costs incurred and work completed
 Offered input and review during development of protocols, Case
Report Forms, Project Plans
Oversaw identification and recruitment of Investigators for clinical
trials in accordance with timelines and contract, including
negotiation of acceptable budgets
Interacted with Medical Monitors and Investigators regarding patient
qualifications for enrollment
Interacted with core project team members to assure project remained
on time
Oversaw budget and contract milestones
Served as mentor and trainer of Project Managers
Organized client meetings and Investigators' Meetings
Covance Princeton, NJ
Director, Site Services 2004 to 2005

Was responsible for operations, resource, and financial management

for approximately 300 individuals performing study site management,
including offices in Montreal, Princeton NJ, Radnor PA, Nashville TN,
and Buenos Aires
Operations management responsibility:
* ensured superior project performance (on-time, on-budget) including
meeting or exceeding client expectations
* supported sales activity
* supported proposal development and the bidding process
* ensured global standardization of processes and process improvement
and efficiency
Resource management responsibilities:
* ensured optimal utilization and profitability of all staff allocated
to the Site Services Center as well as line management for 8 Senior
Managers
Financial responsibility:
* managed revenue and operating margin performance to agreed targets
Covance Princeton, NJ
Director of Operations 2001 to 2004
Operations; Resourcing; Financial Management; Client Management;
Direct Reporting of up to 12 Project Directors and Project Managers;
Indirect Reporting of 80 to 100 individuals in Montreal, Princeton and
Nashville
- Responsible for operations, resource, and financial management for
client groups
- Interface with multiple functional departments to develop cohesive
strategies to ensure client deliverables and client satisfaction
Operations management responsibility:
* ensured superior project performance (on-time, on-budget) including
meeting or exceeding client expectations
* supported sales activity
* supported proposal development and the bidding process
* ensured global standardization of processes and process improvement
and efficiency
Conducted regular project reviews to assess progress against
timelines and budget, assess client satisfaction and identify
proactive strategies to insure success
Provided clinical input to Business Development for bidding

Resource management responsibilities:

* ensured utilization and profitability of all staff allocated to the
Client Project Group as well as line management for the majority of
staff allocated to the Client Project Group
Had direct report supervision of 5-10 Project Directors and Project
Managers
Participated in interviewing and hiring of qualified Directors and
Managers
Financial responsibility:
* managed revenue and operating margin performance to agreed targets
Covance Princeton, NJ
Project Director 1999 to 2001
Management of global clinical trial including project and client
management
Participated as International Project Director on a Phase 3 global
clinical trial (11 countries across 3 continents)
Oversaw and assisted in scheduling and tracking of study activities
Offered input to and review in development of protocols, Case Report
Forms (CRFs), and overall Project Plans
Oversaw identification and recruitment of Investigators for clinical
trials in accordance with timelines and contract
Interacted with core project team members to assure project remains
on time
 Oversaw budget and contract milestones
Served as mentor and trainer of Project Managers and Senior Clinical
Research Associates
Covance Princeton, NJ
Project Manager/Sr. Clinical Research Associate 1995 to 1999
Responsible for management of US clinical trials
Scheduled and tracked pre-study, initiation, routine monitoring, and
close-out visits
Supervised and reviewed development of protocols, CRFs, and
monitoring conventions
Identified and recruited Investigators for clinical trials
Tracked and processed Serious Adverse Events (SAEs)
Tracked budget and contract milestones

Provided daily management and supervision of project Clinical

Research Associates (CRAs)
Organized client and Investigator meetings
Hoechst-Roussel Pharmaceuticals, Inc. Somerville, NJ
Clinical Research Associate 1992 to 1995
Clinical Research Associate- Drug Safety and Surveillance
(1994 to 1995)
Adverse Event (Serious and Non-serious) Tracking and Reporting of
approved and investigational drugs
Received, entered, and followed AEs from investigational studies and
marketed drugs
Provided assessments of seriousness, labeling, and association of
each event

Produced quarterly and annual safety reports for multiple INDs and
NDAs and distribute internally and to the Food and Drug Administration
(FDA)
Worked with the clinical study teams to maintain current and
accurate database of AEs
Clinical Research Associate
(1992 to 1994)
In-house Site Management; Monitoring
Responsible for monitoring and managing clinical trials
 Conducted prestudy, initiation, routine monitoring, and close-out
visits in Phase II and III studies
Developed CRFs and supervised production and distribution
Coordinated use of central laboratory and centralized EKGs
Negotiated bids from CROs for takeover of clinical study
Managed involvement of CRO for Phase II study
Served as Lead CRA by coordinating input of six CRAs who monitored
and managed sites in Phase III study
Tracked SAEs and follow-up information
Updated and revised the Investigator's Brochure on a quarterly basis
Compiled and produced the FDA IND Annual Report on an
investigational compound
Assisted in training of new Clinical Research Assistants

Coordinated involvement of Canadian sites in a multinational project

Coordinated and directed several multicenter Investigator meetings
Negotiated grants; initiated and tracked grant payments
Berlex Laboratories Wayne, NJ
Clinical Research Associate 1990 to 1992
Responsible for monitoring clinical trials
Conducted pre-study, initiation, routine monitoring, and close-out
visits in Phase II and III studies
Monitored and tracked a 20,000 patient post-marketing Phase IV study
Developed CRFs for new protocols
Coordinated multicenter Investigator meetings

Provided ongoing site management

Trained new associate in-house and on-site
Negotiated grants; initiated and tracked payments
Reviewed and monitored progress of edit corrections in data clean-up
Maintained responsibility for site management
Developed monitoring conventions to complement CRFs
Jersey Shore Medical Center Neptune, NJ
Nurse Manager Assistant 1988 to 1990
 Provided care for patients in Pediatrics and Labor and Delivery
Trained new staff nurses to unit policy and procedures
Functioned as charge nurse
Completed payroll and scheduled tasks
Implemented disciplinary actions as required
Ocean County Health Department Toms River, NJ
Public Health Nurse 1985 to 1988
Responsible for providing nursing care and social work to patients
in their homes
Made referrals to community agencies
Assisted in organizing and running the Well Baby Clinics
United States Air Force KI Sawyer Air Force Base, Michigan

Staff Nurse 1982 to 1985

Worked primarily on labor and delivery unit of a 20-bed Air Force
hospital
Officer-in-charge of unit and occasionally of the hospital on