The Head of Toxicology will be responsible for the design, leadership, and implementation of nonclinical safety strategies across Pyxis’ research and development programs. This position will report to the Senior Vice President of Preclinical Research and Development. The individual should be familiar with current practices in the following areas: discovery and regulatory toxicology, DMPK and translational research. As the Head of Toxicology, you will have a strong knowledge of best regulatory practices, extensive experience designing and executing the breadth of nonclinical safety studies to support lead candidate selection through product registration, and a demonstrated ability to make data-driven decisions based on nonclinical and clinical information. The ideal candidate is a creative and innovative scientist who has led nonclinical safety efforts for the successful discovery and development of protein therapeutics across many biologic modalities, such as monoclonal antibodies and antibody drug conjugates. You will work in close collaboration with colleagues in Clinical Development, Translational Sciences, Bioanalysis, Project Management, Research, and Regulatory Affairs to execute the company’s overall development strategy, participate on cross-functional project teams, and contribute to interactions with global health authorities.
This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior most levels of the organization, while making strategic and tactical impact on the things that matter most – driving our science to help patients.
- Lead the nonclinical safety strategy with vision to create scientifically sound, innovative, and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate expedient development from discovery research to Phase 1 and on to registration.
- Independently represent Toxicology as a member of program, nonclinical, and clinical trial working teams, and contribute to candidate selection strategy, and design, execute, and finalize nonclinical study reports.
- Partner with the discovery group and work with nonclinical DMPK colleagues to optimize nonclinical models and inform first in patient clinical dosing strategies.
- Review nonclinical study reports, in conjunction with Pharmacology / DMPK and preparing submission documentation.
- Identify and manage consultants and vendors to support toxicology studies.
- Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from nonclinical safety studies and programs.
- Collaborate cross functionally with all relevant areas to support corporate objectives.
- Other duties as periodically assigned.
- Ph.D. or equivalent training in toxicology or related disciplines with at least 5 years of bio/pharmaceutical industry drug development experience in nonclinical safety/toxicology required
- Strong understanding of toxicology principles, the drug development process and regulatory guidance to support nonclinical safety strategies for FIH studies through product registration
- Experience with preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, FIH starting dose justifications, briefing documents, nonclinical study reports, CTA and filing documents, while working in collaboration with cross functional teams
- Experience in regulatory submissions for small molecules, biologics, and ADCs preferred, with a focus on nonclinical and clinical development global strategy and execution
- Ability to exercise good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required
To apply, please send resume to firstname.lastname@example.org