Summary
Overview
Work History
Education
Skills
Keypublications
Certification
Timeline
Generic

JENNIFER L. HARRIS

Chapel Hill,NC

Summary

Dynamic leader in clinical development with a proven track record at Sequoia Vaccines, enhancing medical affairs strategy and fostering cross-functional collaboration. Specializes in immunology and oncology, driving strategic planning and business growth. Expert in regulatory affairs with a flair for engaging investigators and managing high-performing teams.

Overview

37
37
years of professional experience
1
1
Certification

Work History

VP, Clinical Development

Sequoia Vaccines
St. Louis, MO
04.2022 - Current
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Oversee research, development, and regulatory activities for vaccine and immune-based therapies targeting infectious diseases and cancer
  • Lead clinical trial strategy and implementation, ensuring optimal site engagement and regulatory submissions
  • Manage clinical development and clinical operations teams, ensuring alignment with strategic goals
  • Investigator identification and relationship management
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

VP, Clinical Development, Immuno-oncology

Syneos Health Clinical Solutions
Morrisville, NC
04.2020 - 04.2022
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Established and managed the Immuno-oncology business segment within the oncology sector
  • Provided subject-matter expertise on clinical development strategies for immuno-oncology trials
  • Collaborated cross-functionally to meet client objectives and ensure operational excellence
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Executive Director, Women’s Cancers

Merck & Company
Upper Gwynedd, PA
01.2014 - 03.2020
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Led team of 25 field-based scientists, overseeing strategy, data dissemination and investigator-initiated trial program
  • Worked closely with internal clinical teams to drive the strategic direction of clinical trials in women’s cancers
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Founder and Managing Partner

Pivot Oncology Consulting
Durham, NC
09.2010 - 01.2014
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Consulted for small to mid-sized biotech firms, providing drug development, clinical trial management, and regulatory strategy expertise
  • Focus on First-in-Human (FIH) and Proof-of Concept (PoC) trial design, specializing in immunotherapy approaches
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

VP, Clinical and Regulatory Affairs

Heat Biologics
Chapel Hill, NC
12.2011 - 09.2013
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Managed clinical and regulatory development across multiple oncology pipeline compounds, from IND submissions to clinical trial execution
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Medical Science Liaison – Mid-Atlantic Region

Dendreon Corporation
Seattle, WA
09.2010 - 11.2011
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Served as field-based scientist, providing clinical and scientific support for oncology product research and investigator-initiated trials
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Senior Director, Oncology Drug Development

NovaQuest (a Quintiles company)
Durham, NC
07.2009 - 09.2010
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Oversaw drug development strategy and clinical trial management in the oncology sector
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Oncology Medical Science Liaison – South Atlantic Region

Millennium Pharmaceuticals
Cambridge, MA
11.2008 - 07.2009
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Medical Science Liaison – Mid-Atlantic Region

Celgene Corporation
Summit, NJ
12.2006 - 11.2008
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Clinical Program Team Lead, Oncology

GlaxoSmithKline
Research Triangle Park, NC
01.2001 - 01.2006
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Senior Clinical Project Manager

PharmaResearch Corporation
Morrisville, NC
01.1997 - 01.2001
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Clinical Supplies Project Manager

Duke Clinical Research Institute
Durham, NC
01.1996 - 01.1997
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Pediatric Clinical Pharmacist

University of North Carolina Hospitals
Chapel Hill, NC
01.1992 - 01.1996
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Clinical Research Pharmacist

The National Institutes of Health (NIH)
Bethesda, MD
01.1990 - 01.1992
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Staff Pharmacist

Duke University Medical Center
Durham, NC
01.1988 - 01.1990
  • Company Overview: http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496
  • Http://www.ncbi.nlm.nih.gov/pubmed/?term=Koch%20KM%5BAuthor%5D&cauthor=true&cauthor_uid=26571496

Education

Doctor of Pharmacy -

University of North Carolina at Chapel Hill
Chapel Hill, NC
05.2000

Bachelor of Science - Pharmacy

University of North Carolina at Chapel Hill
Chapel Hill, NC
05.1988

Skills

  • Medical Affairs Strategy and Leadership
  • Clinical Development & Clinical Trial Management
  • Immunology & Oncology
  • Regulatory Affairs & Clinical Trial Design
  • Strategic Planning and Business Growth
  • Product Launch Support
  • Cross-functional Collaboration
  • Investigator Engagement & Scientific Communication
  • Leadership & Team Management
  • Scientific Publication Planning & Advisory Boards
  • Creative Problem-solving and Technology Deployment

Keypublications

  • Perer E, Stacey H, Eichorn T, Hughey H, Lawrence J, Cunningham E, Johnson MO, Bacon K, Kau A, Hultgren SJ, Hooton TM, Harris JL., Case report: Long-term follow-up of patients who received a FimCH vaccine for prevention of recurrent urinary tract infections caused by antibiotic resistant Enterobacteriaceae: a case report series., Front Immunol., 03/13/24, 10.3389/fimmu.2024.1359738, 38545110, PMC10966921
  • Harris J, Stocum M, Roberts L, Jiang C, Lin J, Sprott K., Quest for the Ideal Cancer Biomarker: An Update on Progress in Capture and Characterization of Circulating Tumor Cells., Drug Dev Res, 02/13, 10.1002/ddr.21072
  • Johnston S, Trudeau M, Kaufman B, Boussen H, Blackwell K, LoRusso P, Lombardi DP, Ben Ahmed S, Citrin DL, DeSilvio ML, Harris J, Westlund RE, Salazar V, Zaks TZ, Spector NL., Phase II study of predictive biomarker profiles for response targeting human epidermal growth factor receptor 2 (HER-2) in advanced inflammatory breast cancer with lapatinib monotherapy., J Clin Oncol, 03/01/08
  • Kelly H, Graham M, Humes E, Dorflinger LJ, Boggess KA, O’Neil BH, Harris J, Spector NL, Dees EC., Delivery of a healthy baby after first-trimester maternal exposure to lapatinib., Clin Breast Cancer., 10/06
  • Xia, W, Bacus S, Hegde P, Husain I, Strum J, Liu L, Paulazzo G, Lyass L, Trusk P, Hill J, Harris J, Spector NL., A model of acquired autoresistance to a potent ERbB2 tyrosine kinase inhibitor and a therapeutic strategy to prevent its onset in breast cancer., Proce Natl Acad Sci USA, 05/16/06
  • Burris HA, Hurwitz HI, Dees EC, Dowlati A, Blackwell, KL, O’Neil B, Marcom PK, Ellis MJ, Overmoyer B, Jones SF, Harris JL, Smith DA, Koch KM, Stead A, Mangum S, Spector NL., Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases in heavily pretreated patients with metastatic carcinomas., J Clin Oncol., 08/10/05
  • Spector NL, Xia W, Burris H, Hurwitz H, Dees EC, Dowlati A, O’Neil B, Overmoyer B, Marcom PK, Blackwell KL, Smith DA, Koch KM, Stead A, Mangum S, Ellis MJ, Liu L, Man AK, Bremer TM, Harris J, Bacus S., Study of the biologic effects of lapatinib, a reversible inhibitor of ErbB1 and ErbB2 tyrosine kinases, on tumor growth and survival pathways in patients with advanced malignancies., J Clin Oncol., 04/10/05

Certification

  • North Carolina Pharmacy License

Timeline

VP, Clinical Development

Sequoia Vaccines
04.2022 - Current

VP, Clinical Development, Immuno-oncology

Syneos Health Clinical Solutions
04.2020 - 04.2022

Executive Director, Women’s Cancers

Merck & Company
01.2014 - 03.2020

VP, Clinical and Regulatory Affairs

Heat Biologics
12.2011 - 09.2013

Founder and Managing Partner

Pivot Oncology Consulting
09.2010 - 01.2014

Medical Science Liaison – Mid-Atlantic Region

Dendreon Corporation
09.2010 - 11.2011

Senior Director, Oncology Drug Development

NovaQuest (a Quintiles company)
07.2009 - 09.2010

Oncology Medical Science Liaison – South Atlantic Region

Millennium Pharmaceuticals
11.2008 - 07.2009

Medical Science Liaison – Mid-Atlantic Region

Celgene Corporation
12.2006 - 11.2008

Clinical Program Team Lead, Oncology

GlaxoSmithKline
01.2001 - 01.2006

Senior Clinical Project Manager

PharmaResearch Corporation
01.1997 - 01.2001

Clinical Supplies Project Manager

Duke Clinical Research Institute
01.1996 - 01.1997

Pediatric Clinical Pharmacist

University of North Carolina Hospitals
01.1992 - 01.1996

Clinical Research Pharmacist

The National Institutes of Health (NIH)
01.1990 - 01.1992

Staff Pharmacist

Duke University Medical Center
01.1988 - 01.1990

Doctor of Pharmacy -

University of North Carolina at Chapel Hill

Bachelor of Science - Pharmacy

University of North Carolina at Chapel Hill
JENNIFER L. HARRIS