Summary
Overview
Work History
Education
Skills
Publications
Awards
Patents
Timeline
Generic

Erin Henitz

Ringoes,USA

Summary

Pharmaceutical professional with over 20 years of experience in drug development. Proven leader in cross-functional team management, enhancing productivity through collaboration. Skilled in strategic problem-solving and mentoring, fostering a culture of continuous improvement. Adept at influencing and negotiating within matrix environments to prioritize and allocate resources effectively.

Overview

23
23
years of professional experience

Work History

Vice President, Head of Translational and Quantitative Science Data Management & Clinical Biomarker Operations

Genmab US, Inc.
Princeton, USA
02.2024 - Current
  • Define and drive enterprise strategy for biomarker operations, clinical lab automation, GCP quality management, companion diagnostics, and translational data management, optimizing cross-functional synergies across precision medicine disciplines.
  • Led a transformative insourcing initiative for clinical biomarker and clinical genomics operations, resulting in operational efficiency gains and an annualized cost savings of $10.4 million.
  • Spearheaded the strategic negotiation and execution of diagnostic contracts across three major programs, delivering more than $20 million in cumulative cost savings.
  • Oversee complex operational portfolios, ensuring project excellence, regulatory compliance, and high standards of scientific rigor and quality.
  • Champion process innovation and digital automation to enhance data fidelity, lab scalability, and programmatic delivery speed in support of accelerated oncology development timelines.
  • Architect and sustain a robust global GCP-aligned quality management framework to support future-forward translational and diagnostic capabilities.
  • Mentor and lead a high-impact team, cultivating leadership growth and advancing the company’s strategic goals in clinical precision medicine.

Senior Director, Global Head of Precision Medicine Operations & Diagnostics

Genmab US, Inc.
Princeton, USA
05.2023 - 02.2024
  • Accountable for the oversight and management of translational research and biomarker strategies with a special focus on all operational aspects and overall integrity of clinical trials while implementing translational and clinical objectives in early and late phase oncology clinical trials.
  • Lead development and execution of CDx strategies across the portfolio, ensuring integration with CDTs and development partners.
  • Lead cross program diagnostic strategies and disease level strategies for CDx e.g., Minimal Residual Disease in heme malignancies.
  • Identify efficiencies and opportunities to accelerate and maximize the impact of translational/diagnostic strategies, working closely cross-functionally and driving those learnings earlier in R&D planning.
  • Responsible for the design, development, and implementation of precision medicine pilots, establishing precision medicine initiatives as well as internal and external collaborations.
  • Chair scientific governance with strategic partners to ensure robust assay readiness for inclusion in trials.

Senior Director, Global Head of Precision Medicine Operations

Genmab US, Inc.
Princeton, USA
10.2021 - 05.2023
  • Accountable for the oversight and management of translational research and biomarker strategies with a special focus on all operational aspects and overall integrity of clinical trials while implementing translational and clinical objectives in early and late phase oncology clinical trials.
  • Lead development and execution of CDx strategies across the portfolio, ensuring integration with CDTs and development partners.
  • Lead cross program diagnostic strategies and disease level strategies for CDx e.g., Minimal Residual Disease in heme malignancies.
  • Identify efficiencies and opportunities to accelerate and maximize the impact of translational/diagnostic strategies, working closely cross-functionally and driving those learnings earlier in R&D planning.
  • Responsible for the design, development, and implementation of precision medicine pilots, establishing precision medicine initiatives as well as internal and external collaborations.
  • Chair scientific governance with strategic partners to ensure robust assay readiness for inclusion in trials.

Senior Director, Head of Biomarker Operations & Trial Management

Genmab US, Inc.
Princeton, USA
01.2020 - 10.2021
  • Responsible for driving vendor selection and oversight of clinical and biomarker CROs ensuring execution of Genmab’s clinical trials in alignment with agreed upon budget and timelines and in accordance with all applicable regulations.
  • Provide leadership in the sourcing strategy, including both CRO support models and central and specialty labs ensuring all supporting external resources critical for the effective execution of oncology studies.
  • Ensure timely delivery of results across all programs within the portfolio, consistent with program team and senior management expectations while maximizing the potential impact of Precision Medicine deliverables in Genmab clinical programs.
  • Provide support to US FDA and ex-US regulatory submissions (e.g., EMA) including drafting correspondence related to submission requirements and timelines as well as support during sponsor and CRO inspections.
  • Managed a global cross functional team in 2 locations (Denmark and United States) consisting of 25 direct reports in Trial Management and Biomarker Operations.
  • Grew department from 1 direct report to a team of over 20 employees.
  • Launched new Biomarker Operations function at Genmab while establishing infrastructure, processes, and resources.

Director - Operations Lead, Oncology Translational Research

Janssen Research and Development L.L.C. – Oncology Translational Research
Spring House, USA
04.2017 - 05.2018
  • Accountable for the oversight and management of translational research and biomarker strategies with a special focus on all operational aspects and overall integrity while implementing TR clinical objectives in early and late phase oncology clinical trials.
  • Responsible for establishing and executing an operational model for companion diagnostic development as part of the overarching translational research plan.
  • Lead and mentor a team of 11 reports, responsible for identifying career development areas and coaching plans by offering opportunities for growth and advancement.
  • Accountable for overall translational research out of pocket budget, capital expenses and resourcing.
  • Establish and maintain strong global collaborative relationships with internal and external colleagues to increase productivity across the Oncology portfolio.
  • Develop and streamline innovative processes for early development oncology trials including a large-scale process improvement initiative maximizing efficiencies for Phase 1 studies.
  • Support human resources planning programs including management and staff development and training to meet current and future needs.

Associate Director, Clinical Operations

Janssen Research and Development L.L.C. – Oncology Biomarkers
Spring House, USA
03.2015 - 04.2017
  • Operationalized translational research strategies in alignment with established organizational objectives.
  • Built and fostered relationships across functional areas to achieve project goals.
  • Led and mentored a team of three reports, responsible for identifying career development areas and coaching plans.
  • Led efforts to operationalize companion diagnostic development for late-stage oncology clinical trials.
  • Maintained overall translational research out of pocket budget and resourcing projections.
  • Contributed to the development and content of clinical protocols, informed consent forms, training material, case report forms and other clinical documents.
  • Led communication of the translational research operational strategies with internal and external key stakeholders.
  • Organized and led a cross functional team to develop an internal guidance for sample retention ensuring standardization and cost management.

Senior Associate Scientist

Johnson & Johnson Pharmaceutical Research & Development L.L.C.
Raritan, USA
06.2010 - 07.2012
  • Collaborated with trial managers, CRAs and other members of the clinical teams or investigative sites for tracking and accounting of biomarker samples, obtaining informed consent information, answering IRB questions, timelines and submitting the appropriate biomarker reports.
  • Coordinated with central labs for preparation of sample shipment, extraction, and destruction.
  • Wrote and submitted study specific documentation, protocols, and reports.
  • Interfaced with laboratory staff for all tasks around clinical trials including preparation and assignment of checklists for sample reception, sample destruction, and sample shipment within departmental LIMS system.
  • Perform literature searches for candidate genes and associated SNPs by disease indication, adverse event, or other parameters.
  • Participate in preparation for, and conduct of, FDA and internal QA inspections and audits.

Sample Bank Coordinator

Bristol-Myers Squibb Company – Pharmaceutical Research Institute
Hamilton, USA
05.2002 - 01.2005
  • Coordinated with clinical teams to set up new pharmacogenomics (PGx) and exploratory research studies.
  • Built and maintained relationships with departmental and clinical team members to ensure efficient operation of clinical research studies, which involve sample banking.
  • Ensured consistency between samples collected for research studies and data captured on case report forms in collaboration with clinical team members.
  • Supervised and trained new interns for department.
  • Developed new Sample Banking System for tracking and storage of genetic samples.

Education

Master of Science - Biotechnology Management

University of Maryland University College (UMUC)
Adelphi, MD

Bachelor of Science - Biology

The Richard Stockton College of New Jersey
Galloway, NJ

Skills

  • Project management
  • Biomarker operations
  • Translational data management
  • Clinical trial oversight
  • Operational efficiency
  • Regulatory compliance
  • Contract negotiation

Publications

Blum, J., Masters, G., Chiu, C., Si, H., Gale, J., Grimm, L., Ma-Edmonds, M., Loya, M., Bachu, M., Jabado, O., Soong, D., Zhang, J., Wielgos-Bonvallet, M., Bottrel, N., Henitz, E., Higgs, B., Sasser, K., Jure-Kunkel, M., Fereshteh, M., Deep Peripheral T Cell Immune-Profiling in Relapsed/Refractory Non-Hodgkin Lymphoma: Evaluation of Baseline Samples from the Epcoritamab Epcore NHL-1 Trial., Poster presented at the 64th American Society of Hematology Annual Meeting and Exposition, 12/01/22, Ma-Edmonds, M., Masters, G., Jabado, O., Grimm, L., Bachu, M., Loya, M., Suppa, G., Blum, J., Soong, D., Si, H., Higgs, B., Bottrel, N., Henitz, E., Chiu, C., Sasser, K., Fereshteh, M., Comprehensive Immunophenotyping and Genomics from Single Blood Tube for T-cell Dynamics in Clinical Trials., Poster presented at the 2022 SITC Annual Meeting, 11/01/22, Monk, B. J., Ghatage, P., Parekh, T., Henitz, E., Knoblauch, R., Matos-Pita, A. S., Nieto, A., Park, Y. C., Cheng, P., Li, W., Favis, R., Ricci, D., Poveda, A., Effect of BRCA1 and XPG Mutations on Treatment Response to Trabectedin and Pegylated Liposomal Doxorubicin in Patients with Advanced Ovarian Cancer – Exploratory Analysis of the Phase 3 OVA-301 Study., Annals of Oncology, 10.1093/annonc/mdv071

Awards

  • 2023, Drug Registration: EPKINLY (epcoritamab-bysp)
  • 2021, Drug Registration: TIVDAK (tisotumab vedotin-tftv)
  • 2016, J&J Platinum Encore Award: Development of clinical trial navigator for use in early and late oncology trials
  • 2015, Drug Registration: DARZALEX (daratumumab)
  • 2013, Drug Registration: IMBRUVICA (ibrutinib)
  • 2013, J&J Standards of Leadership Award: Imbruvica (Ibrutinib) submission
  • 2012, J&J Standards of Leadership Award: Achievements for the high school mentoring program
  • 2011, Drug Registration: ZYTIGA (abiraterone acetate)
  • 2010, J&J Innovation Award: Innovation in sample tracking methods
  • 2005, Drug Registration: VELCADE (bortezomib)

Patents

Predictors for cancer treatment, Janssen Pharmaceutica NV, Ricci D, Li W, Henitz E., 9,322,066, 04/26/16

Timeline

Vice President, Head of Translational and Quantitative Science Data Management & Clinical Biomarker Operations

Genmab US, Inc.
02.2024 - Current

Senior Director, Global Head of Precision Medicine Operations & Diagnostics

Genmab US, Inc.
05.2023 - 02.2024

Senior Director, Global Head of Precision Medicine Operations

Genmab US, Inc.
10.2021 - 05.2023

Senior Director, Head of Biomarker Operations & Trial Management

Genmab US, Inc.
01.2020 - 10.2021

Director - Operations Lead, Oncology Translational Research

Janssen Research and Development L.L.C. – Oncology Translational Research
04.2017 - 05.2018

Associate Director, Clinical Operations

Janssen Research and Development L.L.C. – Oncology Biomarkers
03.2015 - 04.2017

Senior Associate Scientist

Johnson & Johnson Pharmaceutical Research & Development L.L.C.
06.2010 - 07.2012

Sample Bank Coordinator

Bristol-Myers Squibb Company – Pharmaceutical Research Institute
05.2002 - 01.2005

Master of Science - Biotechnology Management

University of Maryland University College (UMUC)

Bachelor of Science - Biology

The Richard Stockton College of New Jersey

Similar Profiles

CREATE PROFILE