The Director is primarily accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall global nonclinical regulatory submission strategy and coordination for multiple company portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and NDA/BLA packages. The individual represents the department at the project team level while directing outsourced activities in collaboration with study monitors, to enable timely high-quality project deliverables.
Job Responsibilities and Requirements:
- The individual is a self-starter with excellent management capabilities and is a critical part of an innovative team that to support the company’s drug development process.
- Conceptualizing, developing, revising, and finalizing toxicology (GLP and non-GLP) study designs, reports and nonclinical sections for IND and NDA/BLA submissions, as well as required minor and major submissions to ensure regulatory compliance.
- Critically review and edit CRO nonclinical toxicology study reports, analyze and interpret data, and coordinate report finalization with the help of nonclinical study monitors.
- Provide critical input on nonclinical pharmacology, and pharmacokinetic programs, protocols, reports, and regulatory content.
- Ensure documentation consistent with global regulatory and compliance requirements.
- Manage and monitor nonclinical studies (GLP and non-GLP) at the CROs per company vendor management SOPs and ensure global regulatory/compliance requirements are met/exceeded
- Provide analysis, interpretation, and visualization of nonclinical pharmacology, PK, and toxicology data in preparation for internal department communication and final study reports.
- Leadership and participation on cross-functional teams as nonclinical development expert to ensure proper integration of these activities into overall project plans
- Partner with and provide subject matter expertise to key internal constituencies (regulatory, Quality, Clinical, CMC and formulations, Drug safety, Medical affairs) and their external contractors or collaborators.
- Contribute to departmental processes such as SOP’s and templates
- Maintain a current understanding of relevant literature and methodology, as well as the scientific literature related to the specific company pipeline products and R&D projects.
- DVM or Ph.D. in Pharmacology /Toxicology or Biological Sciences required with 7-10 years of industry experience in conducting biologics and pharmaceutical research and development. DABT required.
- Experience with both small and large molecules, for oncology and non-oncology disease targets, during early/late-stage clinical development and post-marketing.
- Experience in outsourcing, vendor management, and interfacing with internal Finance and legal groups, establishing and managing consultants and CROs driving timely delivery of clear, accurate, and well-written nonclinical study data; as well as real-time communication of unexpected outcomes and mitigation plans.
- Strong knowledge of FDA, EMA, and ICH guidance documents including GLP regulations
- Required experience in authoring regulatory submissions, including full BLA/NDAs or significant sNDAs, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.
- Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical activities, setting up drug candidates for success at all stages of development.
- Working knowledge of CMC, and product quality, to enable impurity assessment and justification of specifications.
- Demonstrated experience in evaluating PK/PD correlations, PK modeling, and parameter estimation a plus.
- Ability to synthesize and interpret diverse, multidisciplinary data sets.
- Strong verbal communication skills accompanied by scientific writing skills.
- Enjoys and thrives in a fast-paced, multi-tasked, and hands-on environment.
For More Information Apply or Contact Brad McMillan at 704-946-8209 or Brad@RPMResearch.Solutions