The Head, DMPK will be responsible for the design, leadership, and implementation of DMPK strategies across Pyxis’ research and development programs. This position will report to the Senior Vice President of Preclinical Research and Development. As Head, DMPK, you should be familiar with current practices in the following areas: clinical pharmacology, DMPK, and bioanalytical assays. You will have a strong knowledge of best regulatory practices, extensive experience designing and executing DMPK studies, and a demonstrated ability to make data-driven decisions based on pre-clinical and clinical information. This individual will work in close collaboration with colleagues in Clinical Development, Clinical Operations, Biostatistics, Translational Sciences, Bioanalysis, Project Management, Research, and Regulatory 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 DMPK and early Clinical Pharmacology 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 preclinical to Phase 1
- Independently represent DMPK as a member of program, nonclinical, and clinical trial working teams, and contribute to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct and finalizing clinical study reports
- Partner with the discovery group and work with preclinical DMPK colleagues to optimize preclinical models and inform first in patient clinical dosing strategies
- Review preclinical study reports, in conjunction with in vivo Pharmacology / DMPK and preparing submission documentation
- Identify and manage consultants and vendors to support DMPK and Clinical Pharmacology studies
- Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from DMPK studies and programs
- Collaborate cross functionally with all relevant areas to support corporate objectives
- Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines with at least 10 years of bio/pharmaceutical industry drug development experience in DMPK and/or clinical pharmacology required
- Strong understanding of DMPK principles, the drug development process and regulatory guidance to support DMPK and early Clinical Pharmacology strategies
- Experience with preparation of the DMPK portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA and filing documents, while working in collaboration with cross functional team
- Experience in regulatory submissions for ADCs and biologics preferred, with a focus on preclinical 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 email@example.com