Valerie Shultz
Director Nonclinical Development @ Organon
About
• Over 20 years of experience in the pharmaceutical and chemical industries • Excellent experience in project leadership and managerial positions • Proven track record in managing multiple research projects, achieving milestones and timelines in a dynamic, fast paced environment • Highly experienced in interacting with regulatory agencies to support new drug (small molecules) and chemical development and writing regulatory submission documents • Experienced managing toxicology safety studies (using internal labs and CROs): acute, reproduction and developmental toxicity studies, chronic and carcinogenicity studies (oral, intravenous, inhalation and dietary) • Successful technical leader, highly innovative and collaborative • Experienced in identifying molecular mechanisms of action • Strong communication skills, as well as excellent interpersonal skills
United States
Greater Philadelphia
Pharmaceuticals
Pre-clinical Studies, Toxicogenomics, Toxicology, Cell, Drug Development, Drug Discovery, Pharmaceutical Industry, Lifesciences, Cross-functional Team Leadership, R&D, Clinical Development, GLP, Regulatory Affairs, Biomarkers, Genomics, Regulatory Submissions, Pharmacokinetics, Pharmacology, Life Sciences, IND
Experience

Director Nonclinical Development
Landsdale, PA
• Early development lead of 1 small molecule including preclinical risk assessment, IND submission and post IND support up to Phase-2 • Nonclinical development lead for 1 small molecule including preclinical risk assessment and IND submission and established brand support • Nonclinical development support for due diligence teams to in-license drugs and monitoring preclinical studies (toxicology, pharmacology and metabolism) • Member of IQ DruSafe virtual controls group and 3Rs group

Technical Leader, Toxicology
Greensboro--Winston-Salem--High Point Area
• Global Toxicology lead for an insecticide candidate from Stage 1.4 to 3 of development • Member of the Toxicogenomics subteam analyzing differentially expressed genes in 14- and 90-day rat and mouse studies to enable dose selection for longer term studies and to inform the project of potential mechanism of action • Team lead for one direct report and actively recruiting for a Global project toxicology position

Toxicology Manager
King of Prussia, PA
•Manage Toxicology personel to provide toxicology and ecotoxicology support and expertise for product development and maintenance of safety data sheet information. •Serve as toxicology support for the stage gate process of product development. •Lead for GHS training and implementation in the US •Develop regulatory documents that target the appropriate audience (i.e., consumer, EPA, EU Regulatory body, employee) to ensure regulatory compliance, knowledge transfer and facilitate business success. •Serve as the Toxicology chair of the Society of Plastics Industry (SPI) peroxides consortium and a member of the American Society for Heating Refrigeration and Air Conditioning Engineers (ASHRAE) •Expert in REACH, HPV, SNAP and ASHRAE submissions, EDSP, GHS, human and animal risk assessment, litigation support, industry Consortia support, and product advocacy. •Provide risk assessment support for the RCMS program and generate Global Product Safety summaries of high risk products. •Serve as a Study monitor for Toxicology and Ecotoxicology studies in support of product registration. •Experienced in using HESIS/NICE modules within SAP for SDS generation and the GHS rule for hazard classification of mixtures.

Senior Manager Toxicology and Regulated Applications at Arkema
King of Prussia
-Lead team of regulated applications experts to provide in-depth regulatory, technical and program guidance and expertise to Arkema Inc. products for regulated applications, including food processing and packaging, medical device, drug, pharmaceutical, food processing, and pesticide/antimicrobial applications. -Lead Toxicology team to provide health and safety support for new product development, new chemical registrations and SDS hazard assessment. -Supervise data and systems administration of all PS&RA data systems, including SAP EHS, regulatory letter system, labeling systems, SDS workflow etc. Identify and implement effective and efficient technical solutions to address new regulatory challenges such as the EPA chemical data reporting rule, TSCA Inventory Reset, REACH compliance etc.

Principal Research Investigator
•Assisted in the conduct and interpretation of investigative studies in Molecular Toxicology Group and assisted in the preparation of scientific publications and presentations at internal and external scientific meetings. •Serve as a member of the global Molecular Toxicology Expert Group, Project Leader for Molecular and Toxicology projects, lead toxicogenomics data interpretation subteams and presented mechanistic data to project teams to assist in decisions regarding product development. •Serve as a Drug Safety Evaluation Representative for drug discovery and development teams. I have supported the development of compounds in the CNS, internal medicine and inhalation therapeutic areas. I have written nonclinical summaries for IMPDs, CIBs, annual safety updates and developed nonclinical drug development plans. •I have collaborated with Discovery teams as a Drug Safety Representative on precandidate/discovery compounds to screen for potential target organ toxicities prior to entry into development. •Developed biomarkers of target organ toxicity in preclinical animal species.

Post Doctoral Fellow
Chemical Industry Institute of Toxicology
•Conducted research using genomic technologies, radioimmunoassay and immunohistochemistry to determine the molecular mechanism of altered male rat reproductive development following in utero exposure to di(n-butyl)phthalate. •The expression levels of a number of genes were altered with DBP exposure, including a variety of genes involved in signal transduction, cell growth, apoptosis and steroid biosynthesis. •These data suggested that DBP toxicity may be mediated through an inhibition of testosterone biosynthesis resulting in an altered expression of testosterone-repressed genes. •Additional Responsibilities: I designed, planned and organized research projects, prepared project budgets, wrote study protocols, supervised a co-op student, analyzed samples and data, wrote manuscripts, presented research results at local and national meetings, and interacted with member company representatives.
Education

Pathobiology
•My thesis research focused on the characterization of TA1, a novel oncofetal gene, which was initially cloned on the basis of its differential expression in rat hepatomas compared to normal adult liver. •This research not only identified a function for TA1 in amino acid transport, but also raised the issue of the role of nutrition in mediating the adaptive response to cellular injury and repair as well as carcinogenesis.
Valerie Shultz's Contact Information
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