Kimberli Brill, BSN

*** **** ******, **** *******, PA 19380

Cell: 610-***-**** abnd75@r.postjobfree.com

OBJECTIVE: To obtain a fulfilling and challenging position in the

pharmaceutical/biotech industry that will utilize my

leadership, communication and organizational skills.

PROFESSIONAL PROFILE

An Associate Director in clinical development with a proven record of

success in the biotech/pharmaceutical fields. A skilled and detail oriented

leader able to see projects though from concept to completion. Expertise in

oncology clinical trial project management through all phases of drug

development.

PROFESSIONAL EXPERIENCE

Ascenta Therapeutics, Malvern, PA

Associate Director, Clinical Development (January 2006-Present)

Sr. Clinical Project Manager (April 2005-January 2006)

Therapeutic area: Director for the Prostate Cancer, Gastrointestinal

Cancer, and Investigator Initiated/Collaborative Clinical Programs and Lead

for Commercial, Public Relations, and Branding Activities

. Director/ Clinical Project Manager for two Phase I/II open-label US

clinical trials in hormone-refractory prostate cancer; one international

randomized Phase II clinical trial in hormone-refractory prostate cancer;

one Phase I/II open-label US clinical trial in gastroesophageal cancer;

and several investigator initiated trials in various cancer indications.

. Developed and managed all program activities for lead novel pan Bcl-2

inhibitor, including, but not limited to: development of clinical

protocols, clinical development strategy, conduct of study feasibility,

planning of study resources, investigational site selection, development

and oversight of study budgets and timelines, study start-up activities,

patient recruitment, study monitoring, clinical supplies, study closeout

activities, generation of clinical study reports, and scientific

publications.

. Coordinated activities associated with the planning, management and

execution of clinical programs, including the management of Ascenta

Therapeutics' personnel, contracted clinical research associates, and

various contract service providers, such as laboratories, data management

vendors, and Clinical Research Organizations (CROs).

. Established and managed individual study and overall program metrics and

oversaw ongoing tracking and reporting of study progress parameters, risk

management reports, study drug projections, and patient enrollment

projections.

. Lead for Ascenta brand and marketing initiatives including the

development of the company website, nonproprietary name for lead Bcl-2

inhibitor, medical education brochures, patient recruitment materials,

and investigator kits/newsletters.

. Prepared and presented scientific messages, study specific training, and

clinical data to investigators and key opinion leaders at investigator

conferences, educational symposia, scientific meetings, advisory board

meetings, and investigational sites.

. Maintained and leveraged relationships with oncology investigators and

key opinion leaders for the development of current and future oncology

clinical trials.

. Lead for all commercial activities for lead Bcl-2 inhibitor including

forecasting, market research, competitor analysis, and public relations.

. Designed and implemented the launch of three unique electronic data

capture (EDC) systems used across multiple studies.

. Responsible for line management and operational effectiveness of Sr.

Clinical Project Manager, Study Managers, and trial support staff for

clinical studies within the prostate cancer program. Ensured

professional development, core competencies, training and compensation.

. Performed transitional duties during company start-up efforts including;

development of Standard Operating Procedures (SOPs), safety management,

data management, drug supply management, clinical contract and budget

negotiation.

. Worked with the clinical development team to create new job descriptions,

job titles, and a career development path within the department.

GlaxoSmithKline, Collegeville, PA

Sr. Clinical Development Scientist (September 2002-March 2005)

Therapeutic area: Lead for Colorectal Cancer and Metastatic Breast Cancer

Clinical Investigations

Awards: Recipient of the Bronze Recognition Award

. Developed concept protocols, full protocols, protocol amendments, and

case report forms for global Phase II/III oncology clinical trials.

. Reviewed and compiled essential data to prepare and author key messages

for publications, clinical study reports, and regulatory submissions.

. Prepared and presented scientific messages, study specific training, and

clinical data to investigators and key opinion leaders at investigator

conferences, educational symposia, scientific meetings, advisory board

meetings, and investigational sites.

. Partnered with Clinical Operations to ensure the following: site

selection met clinical and business objectives, targeted recruitment

goals were achieved, global registration trial timelines were delivered,

and internal and external resources were managed.

. Provided clinical/scientific expertise for the implementation of oncology

and project specific training programs and training materials for

internal and external staff.

. Maintained and leveraged relationships with oncology investigators and

key opinion leaders for the development of current and future oncology

clinical trials.

. Provided clinical and scientific input to US and global

commercial/marketing groups in support for commercialization efforts of a

novel dual ErbB inhibitor for the treatment of metastatic HER-2 positive

breast cancer.

. Managed and coordinated the authoring of the final clinical study report

for a completed Phase II clinical trial.

. Assisted in reviewing and compiling data for the annual IND study report

and Investigator's Brochure update.

ImClone Systems Incorporated, Somerville, NJ

Clinical Project Manager (July 2001- August 2002)

Therapeutic area: Phase I, II, and III Clinical Investigations in

Colorectal Cancer and Acute Myeloid Leukemia (AML)

. Assisted with an electronic Biologic License Application (eBLA)

submission for EGFR monoclonal antibody candidate, including, but not

limited to: review of data tables/listings, format of the application,

and verification of data/ information across multiple studies.

. Prepared investigational sites for Quality Assurance (QA) inspections by

the sponsor and the FDA in preparation for BLA candidate review and

approval.

. Managed a CRO for the overall conduct (e.g. clinical project management,

data monitoring, data management, safety monitoring) of a Phase II

clinical trial.

. Facilitated working relationships with oncology key opinion leaders for

the development and implementation of a Phase I program for a novel VEGFR-

2/KDR inhibitor in AML.

. Developed and critiqued investigational protocols and case report forms

for Phase I, II, and III clinical trials.

. Performed regional feasibility, recruited investigational sites, and

implemented all study start-up efforts for a global Phase III

registration clinical trial in colorectal cancer.

. Planned and presented topics for a multinational investigator meeting for

a Phase III registration clinical trial in colorectal cancer.

. Prepared and distributed status reports and study analyses for ongoing

clinical trials.

. Developed the following standard operating procedures (SOPs) and trained

clinical staff on their implementation: Conducting Pre-Investigational

Site Visits, Conducting Study Initiation Visits, Conducting Interim

Monitoring Visits, Case Report Form and Data Clarification Form

Bookmarking and Linking for an Electronic Biologic License Application

Submission, and Dealing with Potential Fraud or Misconduct in Clinical

Investigations.

Covance, Inc., Princeton, NJ

Clinical Research Assistant through Clinical Research Associate II (May

1999- July 2001)

Therapeutic area: Phase I, II, and III Clinical Investigations in Lung

Cancer

. Coordinated all aspects of clinical trial execution, including but not

limited to: overall site management, regulatory document collection and

review, study drug shipments/accountability, coordination and

distribution of clinical and non-clinical trial supplies, negotiation of

trial and investigational site contracts and budgets, data query review

and resolution, and timely generation of site progress reports.

. Performed site qualification, site initiation, routine monitoring, and

site close-out visits in order to ensure compliance with the study

protocol, federal, state and local regulations, and ICH/GCP guidelines.

. Reviewed case report forms (CRFs) to identify erroneous, incomplete, or

implausible data.

. Generated queries to resolve problematic data identified during the

review process and evaluated responses to assure the database was updated

accordingly.

. Trained junior personnel in performing site qualification, site

initiation, routine monitoring and site close-out visits, as well as

regulatory document review and company SOPs.

. Performed regional feasibility and recruited investigational sites for

participation in two Phase II lung cancer clinical trials.

. Developed and maintained project management tracking tools, including but

not limited to: patient status reports, investigator contracts,

regulatory documents, study drug accountability, serious adverse event

reconciliation, data receipt and entry, and protocol

deviations/violations.

. Developed and maintained study specific plans/manuals, study file

binders, and informed consent form templates.

Medical Center at Princeton, Princeton, NJ, May 1998- May 1999

Telemetry Unit

Responsible for all patient orders, admissions, transfers, discharges,

medication transcription, maintained and updated computerized patient

records, and prioritized patient needs.

EDUCATION

The College of New Jersey, Ewing, NJ, May 1999

Bachelor of Science in Nursing, graduated Cum Laude

Recipient of the New Jersey League for Nursing Award

COMPUTER SKILLS

Windows XP ? MS Word ? MS Excel ? MS PowerPoint ? MS Project ? MS Outlook ?

MS Publisher ? Adobe Publisher ? Adobe Acrobat ? Lotus Notes ? Intuit;

Quickbase ?TrialMaster EDC System ? eTrials EDC System ? Medidata Rave EDC

System

PUBLICATIONS

Anthony L. Fields, David Rinaldi, Charles Henderson, Colin Germond, Luis

Chu, Kimberli Brill, Lance Leopold, Mark Berger. An Open-Label Multicenter

Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line

Therapy in Patients with Metastatic Colorectal Cancer. ASCO Annual Meeting

Abstracts, 2005; Abstract- No. 3583.

G. Liu, G. Wilding, B. Somer, W.K. Kelly, L.H. Leopold, K. Brill . An

Open-Label, Multicenter, Phase II Study of Single-Agent AT-101 in Men with

Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific

Antigen (PSA) Levels who Have Not Received Prior Chemotherapy. ASCO

Prostate Cancer Symposium Abstracts, 2007; Abstract - No. 258.

G. MacVicar, B. Curti, B. Somer, F. A. Greco, K. Brill, L. Leopold. An

Open-Label, Multicenter, Phase I/II Study of AT-101 in Combination with

Docetaxel (D) and Prednisone (P) in Men with Hormone Refractory Prostate

Cancer (HRPC). ASCO Genitourinary Symposium Abstracts, 2008; Abstract -

No. 152.

G. MacVicar, B. Curti, B. Somer, F. A. Greco, K. Brill, L. Leopold. An

Open-Label, Multicenter, Phase I/II Study of AT-101 in Combination with

Docetaxel (D) and Prednisone (P) in Men with Hormone Refractory Prostate

Cancer (HRPC). ASCO Annual Meeting Abstracts, 2008; Abstract - No. 16043.

G. MacVicar, F. A. Greco, J. Reeves, B. Curti, B. Poiesz, B. Somer, K.

Brill, L. Leopold. An open-label, multicenter, phase 1/2 study of AT-101

in combination with docetaxel and prednisone in men with hormone refractory

prostate cancer (HRPC). 20th EORTC-NCI-AACR Symposium on Molecular Targets

and Cancer Therapeutics, 2008; Abstract- No. 209.

G. Liu, W.K. Kelly, G. Wilding, L. Leopold, K. Brill, B. Somer. An Open-

Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men with

Castrate-Resistant Prostate Cancer (CRPC). Clinical Cancer Research

2009;15(9) May 1, 2009.

Anthony Fields, Colin Germond, Lance Leopold, Maria Koehler, Cristina

Oliva, Kimberli Brill, Steven Stein. Efficacy and Safety of Lapatinib

Monotherapy in Metastatic Colorectal Cancer After Progression on a 5-

Fluorouracil-Based First-Line Combination Regimen. Annals of Oncology,

October, 2009 (publication pending).

REFERENCES

Available Upon Request

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