Summary
Overview
Work History
Education
Skills
Areas Of Expertise - Therapeutic Experience
Associations And Board Of Directors
Publications
References
Timeline
Generic

Kim Paulsen

RIVERTON

Summary

Possesses over 25 years of experience delivering cross-functional leadership to project teams, ensuring adherence to specified budgets and timelines while complying with regulatory guidelines and requirements. Extensive experience in orchestrating and overseeing global programs from IND to NDA Submission, pinpointing resource requirements, and evaluating operational quality and risk throughout project life cycle. Expertise in clinical trial phases I-IV, focusing on first-in-human studies and portfolio planning in oncology and hematology, with 20 years of experience. Proven track record in managing investigator-initiated studies and cooperative group studies, alongside expanded access programs. Experience spans biotechnology companies, mid-size and large pharmaceutical companies, clinical research organizations, and clinical site operations.

Overview

27
27
years of professional experience

Work History

President & Principal Consultant, Clinical Operations

KHP Consulting, LLC
Riverton
09.2022 - Current
  • Offering my clients 25+ years of clinical research experience in multiple therapeutic areas in a wide variety of settings, including biotechnology, mid-size pharmaceutical, site level and contract research organizations.
  • Projects:
  • LAVA Therapeutics: Global Lead, AML/ MDS Program
  • Phase 1, FIH in r/r AML and MDS: Supported IND Submission, co-designed and co-authored protocol; point person for vendor selection, study start-up, site selection, patient enrollment; supported data management, clinical supply, quality, global regulatory
  • ClinSmart LLC: Director Project Management
  • Oversaw all clinical programs that were being managed by CRO
  • Actuate Therapeutics: Global Lead, Pancreatic Program
  • Lead for Phase 1/ 2 pancreatic program
  • Certara: Clinical Operations Division
  • Authored SOPs and Operational Plan Templates

Senior Director, Clinical Operations

Elicio Therapeutics
Boston
12.2021 - 09.2022
  • Responsible for the management of clinical trials for any given product within the portfolio. Responsible for the mentoring and management of other clinical operations staff within the program. The primary focus was the operational strategy for the product, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance.
  • Served as Program Oversight Lead for the company, contract research organizations (CROs), vendors and clinical sites involved in the assigned program
  • Developed program strategy, maintained budget planning/forecasting and clinical trial metrics
  • Attended Clinical Operations senior leadership meetings and maintained close communication with other Clinical Operations senior staff to support knowledge sharing across departments
  • Provided leadership, including mentoring, management and support to staff assigned to program to ensure all clinical trials within the program are operationalized and managed in alignment with strategy and compliance standards
  • Oversaw all activities of assigned Clinical Operations team in clinical trial management (from study start up to study closure), including vendor and site identification and start-up, ongoing trial management and quality/risk management evaluation
  • Contributed to clinical trial design and implementation planning to ensure optimized clinical development plans
  • Provided technical expertise for the development of clinical documents (protocols, monitoring plans, clinical study report, investigator brochures, etc.) and trial conduct
  • Oversaw management of cross-functional study team meetings to ensure proactive communication of clinical trial updates, metrics and issues for all cross functional aspects
  • Led risk mitigation and escalation activities both internally as well as with sites and vendors
  • Ensured consistency of process across studies within assigned program as appropriate and worked with Clinical Development leadership to bridge across programs as needed
  • Coordinated the team operations with internal and external collaborators (cross-functional project team and study vendors) to ensure operational excellence.

Senior Director, Clinical Operations

Edgewise Therapeutics
Boulder
09.2020 - 11.2021
  • Provided cross-functional team management for clinical operations and strategic evaluation of the company’s pipeline portfolio. Had accountability for the successful and timely completion of projects leading to clinical study initiation and completion as well as regulatory approval while maintaining the quality and compliance of clinical development activities. Responsible for decisions that involved clinical strategy, operations, and tactics. This position was highly influential across all R&D functions that contributed to the clinical development work.
  • Established clinical development plan and clinical trial development in close collaboration with the Chief Medical Officer
  • Drove implementation of development programs by establishing development and operational strategy, schedules, budgets, and financial analysis with a cross-functional team
  • Coordinated team deliverables for project completion. Worked at the cross-functional interfaces across all functional areas (research, clinical/medical, regulatory, CMC, and business support functions) during the planning and execution of the program in order to achieve program objectives and deliverables.
  • Maintained direct involvement with Development, Regulatory, Manufacturing, Legal organizations, and with external stakeholders
  • Participated in business contract negotiations for new suppliers and consultants and in the evaluation process for future development projects
  • Recommended, implemented and managed the appropriate program structure and standard performance metrics throughout all phases from initiation to scale-up
  • Provided clear direction on product development requirements to meet expectations of external customers and internal business stakeholders
  • Had a broad understanding of the bigger picture and how clinical operations and development works across all functions including clinical trials, drug supply, CMC, Regulatory, Data Management/Stats, Phase I, PK/PD, Drug Analysis, and commercial
  • Provided financial analysis and justification for new products
  • Continuously evaluated program(s) progress to anticipate, identify and address critical issues and risks. Made recommendations to the CMO regarding the appropriate risk when there was substantial program impact.

Senior Director, Clinical Operations

Celsion Corporation
Lawrenceville
10.2019 - 07.2020
  • Oversaw the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Participated in the design and implementation of scientific methods for clinical protocols, data collection systems and final reports. Monitored adherence to protocols and determined study completion. Interacted with various inside/outside groups to facilitate clinical trials research. Responsible for ensuring Celsion’s FDA, GCP compliance and, where necessary, international regulations.
  • Responsible for management of:
  • Clinical Monitoring Staff
  • Data Management Staff
  • Contract clinical (CRO) Services
  • Contract Biostatistical Services
  • Contract Medical Writing Services
  • Contract SAS Programming Services
  • An integral part of the NDA team including the following activities:
  • Evaluated and identified NDA CRO, including sending RFPs and participating in Bid Defenses
  • Inspection Readiness including but not limited to identifying risks, historical Storyboarding, participation in Mock Inspection, preparing sites and vendors for audits, auditing TMFs
  • Executed productive DMC and DSMB meetings
  • Negotiated and re-evaluated contracts and bids to ensure we were operating at maximum use of program budgets
  • Oversaw clinical trial sites and vendors identification, evaluation and decision process.
  • Oversaw clinical trial sites and vendors contract agreements, negotiations and adherence.
  • Supervised staff (internal/external) to ensure projects and information are on track according to Clinical plan(s).
  • Provided Executive Management with progress updates as requested

Project Director

Precision for Medicine, Oncology and Rare Disease
Flemington
03.2018 - 10.2019
  • Oversaw and managed all aspects of global clinical research trials.
  • Managed the clinical study budget, ensuring project remains within scope and that any out of scope activities were identified and handled as appropriate.
  • Established tracking metrics to monitor trial and team progress towards project goals.
  • Prepared project status updates for clients and the Precision Oncology Executive Team.
  • Served as a lead member of the Global Project Team with the goal to contribute towards efficient management and execution of trials.
  • Prepared and reviewed protocols and other study documentation.
  • Designed and developed CRF and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).
  • Oversaw all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels.
  • Established, updated, tracked and maintained study specific trial management tools/systems, and status reports.
  • Managed site start up procedures including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings or delegating these tasks as appropriate.
  • Negotiated study budgets and assisted with the execution of investigator contracts.
  • Communicated effectively with both site personnel and Precision Oncology executive management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
  • Developed and maintained good working relationship with investigators and study staff, serving as an ambassador to promote Precision Oncology’s high quality and ethical image.
  • Maintained study tracking, in accordance with the demands of the study.
  • Performed data management activities, including in-house CRF review, query resolution, and assists data management personnel to resolve data discrepancies.
  • Liaised with Medical Monitors to manage Serious Adverse Events, data issues and concerns according to the procedures defined by the study team.
  • Liaised with data management to resolve data discrepancies and ensure all data management study goals are met.
  • Mentored, trained, and supervised staff at a functional level.
  • Assisted with review of clinical study reports.
  • Conducted feasibility work.
  • Provided input to the development of proposals.
  • Evaluated company needs, resources and timelines.
  • Initiated payment requests for investigators.
  • Management of Global Project Managers, Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates, including administrative aspects, and monitoring and performance assessment.

Associate Director, Clinical Operations

Celator Pharmaceuticals, a subsidiary of Jazz Pharmaceuticals
Ewing
12.2006 - 03.2018
  • Advanced in study management roles over 12-year period, achieving titles of Sr CRA, CPM, Sr CPM, and Associate Director
  • Supervised clinical trials in conjunction with clinical operations team.
  • Facilitated successful NDA submission and FDA inspection preparation for IND in acute myeloid leukemia (AML)
  • Oversaw international Phase III, Phase IIB, Investigator Initiated Studies, Cooperative Group Studies, and Expanded Access Program for IND in AML.
  • Co-led Phase I AML study alongside Phase I and Phase II colorectal cancer studies.
  • Co-authored protocols, protocol amendments and informed consents.
  • Coordinated, prepared and compiled Site Operations Manuals, Pharmacy Manuals, study instructions, clinical monitoring plans and project plans.
  • Co-created the eCRF pages.
  • Interacted with multiple groups to drive RFP process and coordinate vendor selection.

Project Manager

Bio-Imaging Technologies, Inc.
Newtown
01.2004 - 12.2006
  • Coordinated and managed activities associated with medical imaging component of clinical trials for corporate clients in pharmaceutical industry.
  • Managed up to 13 clinical trials and 650+ sites at a time.
  • Defined and maintained project timelines by reviewing service agreements and identifying project budgetary requirements.
  • Designed and co-authored clinical research protocols, imaging-related forms.
  • Worked with sponsors to identify and document specific imaging requirements for trial protocols.
  • Presented imaging requirements and procedures at client-sponsored investigator meetings.
  • Conducted in-house project team meetings to review project status and identify and resolve issues.
  • Conducted site training teleconferences.
  • Coordinated conduct of read sessions using independent readers for interpretation of imaging data obtained as part of a clinical trial.
  • Generated project-specific methodology reports, summarizing procedures and methods used in imaging component of clinical trial.

Assistant Director, Clinical Trials

Philadelphia FIGHT (Field Initiating Group on HIV Trials)
Philadelphia
04.2001 - 12.2003
  • Conducted site monitoring visits.
  • Managed all phases of incoming potential industry trials, including Confidentiality Agreement Process, budget phase, and Regulatory Phase.
  • Ensured SOPs, GCPs, and HIPAA Guidelines were adhered to for all ongoing trials.

Research Coordinator

Philadelphia FIGHT (Field Initiating Group on HIV Trials)
Philadelphia
04.2002 - 12.2002
  • Conducted government and pharmaceutical clinical research studies that considered different treatment strategies for HIV positive patients.
  • Attended and presented at conferences, trainings and meetings.

Research Assistant

Philadelphia FIGHT (Field Initiating Group on HIV Trials)
Philadelphia
04.2001 - 04.2002
  • Conducted patient study visits.
  • Performed administrative duties, including completing Case Report Forms, Quality Assurance, and attending weekly meetings to discuss patients who have been lost to care, adverse events and hospitalizations.

Research Assistant

Emotional Beginnings Lab
State College
09.1998 - 12.2000
  • Assisted with study participant site visits.
  • Performed administrative duties, including collecting, entering, coding data using SAS, OCS, MS Word, Access, Excel, compiling, mailing questionnaires and surveys and maintaining case files on 150+ participants.

Education

Bachelor of Arts - Crime, Law and Justice

Pennsylvania State University
State College, PA
12.2000

Skills

  • Strategic leadership
  • Clinical trial management
  • Budget forecasting
  • Project planning
  • Cross-functional collaboration
  • SOP development
  • Regulatory compliance
  • Risk assessment
  • Vendor management
  • Data analysis

Areas Of Expertise - Therapeutic Experience

AML/MDS, Colorectal, CTCL, Glioblastoma, Hepatocellular, Metastatic Breast, Non-SCLC, Ovarian, Pancreatic Cancer, Prostate Cancer, HIV, Muscular Dystrophy

Associations And Board Of Directors

  • President, Board of Trustees, Riverton Free Library Association, Riverton, NJ
  • Vice President, Executive Board, The Cat’s Meow Rescue NJ, Riverton, NJ
  • Member, Historical Society of Riverton, Riverton, NJ

Publications

  • CPX-351 treatment of previously untreated older AML patients with high risk AML markedly increases the response rate over 7+3 in patients with flt3 mutations., Lancet J, Uy G, Cortes J, Newell L, Lin T, Ritchie E, Strickland S, Stuart R, Hogge D, Solomon S, Stone R, Bixby D, Kolitz J, Schiller G, Wieduwilt M, Rao A, Rubenstein S, Stock W, Foster M, Erba H, Goldberg S, Powell B, Podoltsev N, Atallah E, Warlick E, Yee K, Pagel J, Norkin M, Barta S, Sandhu I, Frankfurt O, Gautier M, Larson M, Seiter K, Levy M, Bergeron J, Berdeja J, Kropf P, Shemanski L, Ryan D, Chiarella M, Paulsen K, Louie A, Medeiros B, Haematologica, 2016, 101, 186, 2017-05-31, 5
  • CPX-351: A Randomized Phase 2b Study of CPX-351 v. Intensive Salvage Therapy in '65 Yo First Relapse AML Patients: Initial Efficacy and Safety Report., Jorge E. Cortes, Eric J Feldman MD, Stuart L. Goldberg MD, David A. Rizzieri MD, Kim H. Paulsen, Arthur C. Louie MD, Jonathan E. Kolitz MD, Blood, 118, 21, 2011-11-18, 254
  • CPX-351: A randomized phase IIb study first-relapse patients younger than age 65., J. E. Kolitz, J. E. Cortes, K. Paulsen, A. C. Louie, 2010 ASCO Annual Meeting Trials in Progress Poster Session, 2010-05-20, Journal of Clinical Oncology, 28

References

References available upon request.

Timeline

President & Principal Consultant, Clinical Operations

KHP Consulting, LLC
09.2022 - Current

Senior Director, Clinical Operations

Elicio Therapeutics
12.2021 - 09.2022

Senior Director, Clinical Operations

Edgewise Therapeutics
09.2020 - 11.2021

Senior Director, Clinical Operations

Celsion Corporation
10.2019 - 07.2020

Project Director

Precision for Medicine, Oncology and Rare Disease
03.2018 - 10.2019

Associate Director, Clinical Operations

Celator Pharmaceuticals, a subsidiary of Jazz Pharmaceuticals
12.2006 - 03.2018

Project Manager

Bio-Imaging Technologies, Inc.
01.2004 - 12.2006

Research Coordinator

Philadelphia FIGHT (Field Initiating Group on HIV Trials)
04.2002 - 12.2002

Assistant Director, Clinical Trials

Philadelphia FIGHT (Field Initiating Group on HIV Trials)
04.2001 - 12.2003

Research Assistant

Philadelphia FIGHT (Field Initiating Group on HIV Trials)
04.2001 - 04.2002

Research Assistant

Emotional Beginnings Lab
09.1998 - 12.2000

Bachelor of Arts - Crime, Law and Justice

Pennsylvania State University

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