Leslie Foertsch
Fairfield,OH
Summary
Project and people manager leading clinical trial laboratory programs across neuroscience, cardiology, oncology, vaccines, and rare diseases. Oversees cross-functional delivery, client communication, risk management, and escalation resolution while coaching junior project managers and improving team workflows to keep studies on track.
Overview
24
24
years of professional experience
Work History
Manager, Project Management
Thermo Fisher Scientific/PPD Global Central Laboratories
Highland Heights, KY
06.2024 - Current
- Manages a team of 10 project managers, driving career development through 1:1 coaching, implementing actionable growth strategies, and performance reviews
- Optimized team workflows by identifying process inefficiencies and coaching direct reports on agile delivery methods to enhance project execution
- Liaised with clients, clinical teams, and internal Thermo Fisher departments to resolve issues and implement effective solutions and mitigations
- Conducts weekly client status meetings to resolve study concerns and incorporate feedback into project execution
- Assists in handling client escalations to provide timely resolutions and solid strategies to prevent issue recurrence
- Established high standards for customer service, fostering strong partnerships with clients
Senior Project Manager
Thermo Fisher Scientific/PPD Global Central Laboratories
Highland Heights, KY
10.2023 - 05.2024
- Managed a portfolio of 10-15 clinical trial programs with both large and small pharmaceutical and biotech clients, overseeing $1M+ in project budgets
- Provided oversight and coordination of the operational aspects of the functional areas on assigned clinical trials/projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), applicable regulatory guidelines, and laboratory procedures
- Acted at the partnership level for major clients to further develop client trust and collaboration
- Led Project Management training program for newly hired Project Managers, building competency in clinical trial central laboratory competencies and client satisfaction strategies
- Mentored other Project Managers at various career stages to improve their efficiency and strengthen relationships with internal and external teams
- Managed client escalations, driving timely resolutions and developing strategies to prevent issue recurrence.
- Worked closely with laboratory management to ensure that project deliverables meet customer expectations and Company financial commitments
- Driven to establish and maintain positive and productive relationships with client teams
- Delivered clinical laboratory presentations during study kick-off and investigator meetings, enhancing stakeholder understanding.
- Directed portfolio management for 10-15 clinical trial programs across large and small pharmaceutical and biotech accounts, with oversight of $1m+ project budgets.
- Provided operational leadership across functional areas on assigned trials and projects, aligning work with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), regulatory requirements, and laboratory procedures.
- Represented client partnerships at senior level to deepen trust, collaboration, and long-term engagement.
- Designed and delivered project management training for newly hired project managers, strengthening capability in clinical trial central laboratory operations and client satisfaction strategies.
- Coached project managers at multiple career stages to increase efficiency and improve cross-functional working relationships.
- Managed client escalations in coordination with project teams, driving timely resolution and prevention strategies for recurring issues.
- Collaborated with laboratory management to align deliverables with customer expectations and financial commitments.
- Presented clinical laboratory updates during study kick-off and investigator meetings.
- Portfolio delivery remained on track across 10-15 clinical trial programs for pharmaceutical and biotech clients, with $1m+ in project budgets managed.
- Operational compliance stayed aligned with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), regulatory requirements, and laboratory procedures across assigned clinical trials and projects.
- Project management training for newly hired project managers strengthened readiness in clinical trial central laboratory operations and client satisfaction methods.
- Improved project manager effectiveness through mentoring support across multiple career stages and stronger internal and external team relationships.
- Timely client escalation support contributed to issue resolution and prevention plans for repeat concerns.
- Project deliverables stayed aligned with customer expectations and company financial commitments through close work with laboratory management.
- Positive, productive relationships with client teams remained consistent across ongoing engagement.
- Clear clinical laboratory presentations supported study kick-off and investigator meetings.
- Applied clinical laboratory testing knowledge to enhance project communication supported accurate project communication and execution.
Senior Project Manager
CTI Laboratory Services
Cincinnati, OH
07.2023 - 10.2023
- Planned, implemented, evaluated and completed execution of assigned laboratory clinical trials/projects
- Set goals and timelines; oversaw and motivated team to achieve project milestones within defined timelines and maintain high quality in execution of clinical trials/projects
- Oversaw and coordinated operational aspects of functional areas on clinical trials/projects, ensuring adherence to International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), and relevant regulatory and laboratory procedures
Principal Program/Project Manager
PPD Global Central Laboratories
Highland Heights, KY
08.2019 - 06.2023
- Oversaw and coordinated operational aspects of clinical trials/projects, ensuring compliance with ICH guidelines, GCP, regulatory guidelines, and laboratory procedures
- Monitored project status, timelines, and budgets using Smartsheet dashboards, tracking budget and schedule variance across 10-15 concurrent trials
- Acted as the primary liaison between client, business development, and project teams, thus facilitating the flow of information between parties
- Collaborated with laboratory management to ensure project deliverables met customer expectations and aligned with financial commitments
- Developed strong relationships with client teams to enhance collaboration and communication.
- Provided focused program management services to one of PPD GCL's largest clients
- Prepared and presented clinical laboratory presentations within study kick-off and investigator meetings
- Mentored and managed several junior project managers.
- Acquired comprehensive knowledge of clinical laboratory testing methodologies and protocols.
Biocompatibility Specialist at Ethicon Endo-Surgery
Aerotek/Easi, LLC
Cincinnati, OH
08.2018 - 08.2019
- Contributed to the design and execution of preclinical safety and efficacy studies that assessed the biocompatibility and safety of medical devices, drugs, and combination products according to regulatory requirements.
- Reviewed submission documents for regulatory bodies, ensuring correlation and traceability to preclinical data and adherence to FDA Good Laboratory Practices
- Maintained current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, ICH, FDA, etc.) and compliance requirements (GLP, departmental SOPs, Ethicon Endo-Surgery policies, etc)
- Supported project teams with technical expertise, ensuring alignment with regulatory requirements and enhancing project outcomes
- Analyzed and interpreted data, drawing conclusions, and arriving at timely technical decisions, clearly communicates information to project teams
Laboratory Project Manager
Medpace Reference Laboratories
Cincinnati, OH
08.2016 - 08.2018
- Honed skills in clinical research, project management, and client services to enhance project delivery
- Managed multiple global and US-based clinical trial projects, while establishing positive and productive relationships with past and existing pharmaceutical and bio-tech clients
- Assumed full accountability in managing and ensuring timely, under budget, and quality completion of all aspects of designated clinical protocol
- Acquired expertise in clinical laboratory testing procedures and protocols to ensure compliance and quality.
- Developed and managed laboratory manuals and other study-related documents
- Created specifications and handled the production of specimen collection kits
- Prepared and presented clinical laboratory presentations within study kick-off and investigator meetings
- Served as primary contact for clients regarding laboratory aspects of assigned protocols, fostering strong communication and collaboration
Toxicologist, Global Product Stewardship Department / Color Cosmetics
Procter & Gamble
Cincinnati, OH
01.2013 - 08.2016
- Provided expert oversight to ensure the safety of Procter and Gamble's Color Cosmetics business operations, which involved Cover Girl, Max Factor, Gucci, and Dolce & Gabbana brands
- Oversaw pre-clinical toxicology studies with contract research organizations (CRO), interpreting data to support safety and product claims
- Issued approval for all prototype and test formulations for pre-market research and go-to-market products based on qualitative risk assessment principles
- Monitored project milestones by anticipating and generating early interventions for safety-related challenges
- Coordinated with global project team and suppliers to enhance understanding of product technology and ingredients
- Worked in coordination with Post Market Safety Surveillance, Quality Assurance, Product Development, and production plant in identifying and resolving consumer safety-related and post-launch issues
- Rendered hands-on support to the production plant in ensuring the safety of all products for retail distribution when deviations occurred in the production procedures
- Functioned as an effective member of the internal P&G Contact Dermatitis Expert Team focused on addressing potential issues in relation to products and contact dermatitis
- Maintained strict conformance with Occupational Safety and Health Administration (OSHA) and United States Environmental Protection Agency (EPA) regulations in managing biohazardous materials in collaboration with Laboratory Technical Team
Project Research Manager | Senior Researcher, Global Product Stewardship Department
Procter & Gamble
05.2003 - 01.2013
- Managed multi-regional research projects funded by Cosmetics Europe Trade Association, coordinating with universities in Germany, France, and the UK to ensure alignment with project goals and deliver quarterly status updates to stakeholders to maintain transparency and engagement
- Directed six multi-regional study sites to validate assay transfer and data reproducibility across laboratories, confirming adherence to GLP standards and enhancing confidence in study outcomes
- Led project research for developing and using pre-clinical toxicology methods to identify reproductive toxicity and skin sensitization.
- Strategically utilized animal models in determining the reproductive toxicity of drugs, pesticides, botanicals, and natural products, and novel chemicals to provide the foundation for developing animal-based genomic studies to identify molecular fingerprints of estrogen responses for translation into non-animal cell-based assays
- Conceptualized in vitro assays that served as substitutes for animal models in studying skin sensitization potential of drugs, pesticides, botanicals and natural products, respiratory sensitizers, and novel low-molecular weight chemicals
- Planned and facilitated training programs that provided both hands-on and classroom instruction for the successful conduct of in vitro skin sensitization assays for contractors, interns, industry collaborators, and contract laboratories
- Supervised contractors and interns daily, ensuring project tasks were completed effectively.
- Facilitated external validation and endorsement for Direct Peptide Reactivity Assay with global regulatory agencies, strengthening the assay's credibility and acceptance in regulatory frameworks
Education
Master of Science - Pathology, with Focus on Immunology
University of Cincinnati
Cincinnati, OHBachelor of Science - Biology and Chemistry
Wright State University
Dayton, OHSkills
- Agile Project Management
- Project Portfolio Oversight
- Budget Management
- Financial Oversight
- Risk Management Strategies
- Resource Allocation
- Stakeholder Engagement
- Stakeholder communication
- Problem resolution
- Issue resolution
- Leadership Development
- Strategic thinking
Personal Information
Title: People Manager | Project Manager | Biotechnologist | Toxicologist | Researcher
PUBLICATIONS
- Presentations:
- Foertsch, L. (2008). The Development Peptide Reactivity Assays for the Prediction of Skin Sensitization. Joint Meeting of the Experimental Contact Dermatitis Research Group and the American Contact Dermatitis Society, Montreal, QC Canada.
- Poster Presentation:
- Foertsch, L. (2007). Application of Prediction Models to the Development of a Peptide Reactivity Assay for Screening Contact Allergens. Poster presented at Society of Toxicology Annual Meeting, Charlotte, NC.
- Foertsch, L. (2010). Direct Peptide Reactivity Assay (DPPRA) for Screening Skin Sensitization Potential of Chemicals. Poster presented at Society of Toxicology Annual Meeting, Salt Lake City, UT.
- Foertsch, L. (2011). Intralaboratory Reproducibility of the Direct Peptide Reactivity Assay (DPPRA) to Assess the Robustness of the Current Prediction Model. Poster presented at Society of Toxicology Annual Meeting, Houston, TX.
- Articles and Manuscript:
- Kimber, I., Nookala, S., Davis, C., Gerberick, GF, Tucker, H., Foertsch, L., Dearman, R., Parsonnet, J., Goering, R., Donnelen, M., Morel, J., Koty, M. (2013). Toxic Shock Syndrome: Characterization of Human Immune Responses to TSST-1 and Evidence for Sensitivity Thresholds. Toxicological Sciences, 134 (1): 49-63.
- Horstman, KA, Naciff, JM, Overmann, GJ, Foertsch, LM, Richardson, BD, Daston GP. (2012). Effects of Transplacental 17- -Ethynyl Estradiol or Bisphenol A on the Developmental Profile of Steroidogenic Acute Regulatory Protein in the Rat Testis. Birth Defects Res B Dev Reprod Toxicol. Aug;95(4):318-25.
- Lalko, JF, Kimber, I, Gerberick, GF, Foertsch, LM, Api, A, Dearman, RJ. (2012). The Direct Peptide Reactivity Assay: Selectivity of Chemical Respiratory Allergens. Toxicological Sciences, 129 (2): 421-431.
- Troutman, JA, Foertsch, LM, Kern, PS, Dai, HJ, Quijano, M, Dobson, R, Lalko, JF, Lepoittevin, JP, Gerberick, GF. (2011). The Incorporation of Lysine into the Peroxidase Peptide Reactivity Assay for Skin Sensitization Assessments. Toxicological Sciences, 122 (2): 422-436.
- Gerberick, GF, Troutman, JA, Foertsch, LM, Vassallo, JD, Quijano, M, Dobson, R, Goebel, C, Lepoittevin, JP. (2009). Investigation of Peptide Reactivity of Pro-hapten Skin Sensitizers Using a Peroxidase-Peroxide Oxidation System. Toxicological Sciences, 112 (1): 164-174.
- Gerberick, GF, Vassallo, JD, Foertsch, LM, Price, BB, Chaney, JG, Lepoittevin, JP. (2007). Quantification of Chemical Peptide Reactivity for Screening Contact Allergens: A Classification Tree Model Approach. Toxicological Sciences, 97 (2): 417-427.
- Gildea, LA., Ryan, CA., Foertsch, LM, Kennedy, JA., Dearman, RJ, Kimber, I, Gerberick, GF. (2006). Identification of Gene Expression Changes Induced by Chemical Allergens in Dendritic Cells: Opportunities for Skin Sensitization Testing. Journal of Investigative Dermatology, 126 (8): 1813-1822.
- Naciff, JM, Hess, KA, Overmann, GJ, Torontali, SM, Carr, GJ, Tiesman, JP, Foertsch, LM, Richardson, BD, Martnez, JE, Daston, GP. (2005). Gene Expression Changes Induced in the Testis by Transplacental Exposure to High and Low Doses of 17- -Ethynyl Estradiol, Genistein, or Bisphenol A. Toxicological Sciences, 86 (2): 396-416.
- Ramirez, T, Stein,N, Aumann, A, Remus, T, Edwards, A, Norman, K, Ryan, C, Bader, J,Fehr,M, Burleson, F, Foertsch, L, Wang, X, Gerberick,F, Beilstein, P, Hoffmann, S, Mehling, A, Ravenzwaay, B, Landsiedel,R. (2016). Intra- and inter-laboratory reproducibility and accuracy of the LuSens assay: A reporter gene-cell line to detect keratinocyte activation by skin sensitizers. Toxicology in Vitro. 32: 278-286.
- Natsch, A, Ryan, C, Foertsch, L, Emter, R, Jaworska, J, Gerberick, F, Kern, P. (2009). A dataset on 145 chemicals tested in alternative assays for skin sensitization undergoing prevalidation. Journal of Applied Toxicology 33(11):1337-32.
- Mutschler, J, Gimenez-Arnau, E, Foertsch, L, Gerberick, GF, Lepoittevin, JP. (2009). Mechanistic assessment of peptide reactivity assay to predict skin allergens with Kathon CG isothiazolinones. Toxicol In Vitro. 23(3): 439-46.
PROFESSIONAL DEVELOPMENT
- Continuing Education
- E6 Good Clinical Practice, International Council for Harmonisation (ICH) Training
- Empower 2 Fundamentals: Using the Pro Interface, Waters Educational Series
- Empower 2 Advanced: Acquisition, Processing, and Reviewing Results, Waters Educational Series
- BD FACSanto II Operator Course, BD Biosciences
Timeline
Manager, Project Management
Thermo Fisher Scientific/PPD Global Central Laboratories
06.2024 - Current
Senior Project Manager
Thermo Fisher Scientific/PPD Global Central Laboratories
10.2023 - 05.2024
Senior Project Manager
CTI Laboratory Services
07.2023 - 10.2023
Principal Program/Project Manager
PPD Global Central Laboratories
08.2019 - 06.2023
Biocompatibility Specialist at Ethicon Endo-Surgery
Aerotek/Easi, LLC
08.2018 - 08.2019
Laboratory Project Manager
Medpace Reference Laboratories
08.2016 - 08.2018
Toxicologist, Global Product Stewardship Department / Color Cosmetics
Procter & Gamble
01.2013 - 08.2016
Project Research Manager | Senior Researcher, Global Product Stewardship Department
Procter & Gamble
05.2003 - 01.2013
Master of Science - Pathology, with Focus on Immunology
University of Cincinnati
Bachelor of Science - Biology and Chemistry
Wright State University