Ambrx, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics. Ambrx is based on a fundamental advance in protein biosynthesis that enables the company to genetically engineer proteins with new amino acid building blocks beyond the common twenty, enabling the biosynthesis of proteins with new physical, chemical and pharmacological properties. At Ambrx, we are dedicated to assembling and developing an exceptional team and a breakthrough technology to create the next generation of protein-based medicines.
Ambrx is seeking an experienced and highly motivated Toxicologist to join the Preclinical Science group in our fast-paced and dynamic organization. The successful candidate will play a key role in setting safety pharmacology strategy, designing and executing tolerability and toxicokinetic (TK) studies, overseeing drug metabolism (DM) studies, and supporting pharmacokinetic (PK) studies and modeling as appropriate to help progress novel protein therapeutics from preclinical research into IND enabling studies.
Responsible for all aspects of Toxicology and DMPK functions:
- Design, outsource, and manage non-GLP and GLP toxicology and safety pharmacology studies in support of projects from discovery to early clinical development.
- Prepare study protocols and reports related to toxicology studies.
- Interpret study results from toxicology in conjunction with DMPK and pharmacology studies to estimate therapeutic index.
- May perform/oversee/outsource pharmacology, DMPK studies, PK/PD modeling for dose predictions and/or candidate selection as appropriate.
- Lead early hypothesis-driven investigations into mechanisms of toxicity for the proactive management of potential safety liabilities.
- Communicate study status, timelines and data to key stakeholders.
- Collaborate and interface with other functional areas including biological, bioanalytical and translational sciences, in vivo pharmacology, clinical and regulatory teams to facilitate development and execution of study plans.
- Serve as Toxicology representative on multidisciplinary project teams.
- Contribute to regulatory submissions.
- Stay current with the latest toxicology trends and regulatory requirements.
- Ph.D. in Toxicology, Pharmacology or related discipline with at least 5 years of drug discovery and development experience in the Pharma/Biotech industry.
- Experience in designing and conducting non-GLP and GLP toxicology and pharmacokinetic studies with biologics for lead candidate selection and IND enabling studies is essential.
- Experience in authoring toxicology reports and nonclinical summaries for regulatory submissions is required.
- Experience selecting CROs and managing external contracts.
- Ability to independently interpret results from toxicology studies to guide lead candidate design and selection is required.
- Experience in estimation of human equivalent dose (HED) and maximum recommended starting dose (MRSD) based on results from non-clinical studies is a plus.
- Ability to manage multiple projects simultaneously.
- Certification by the American Board of Toxicology (DABT) is a plus.
- Knowledge of GLP regulations and relevant FDA, EMA, and ICH guidance documents is highly desired.
- Expertise in analysis of PK/PD data and PK modeling and simulation using Phoenix WinNonlin, and contributions to PK/TK reports is preferred.
- Experience working with ADCs, T-Cell engagers for oncology indications is a plus.
- Excellent time management, communication, organizational and collaborative skills.
- Ability to be a self-starter as well as work in an interdisciplinary team.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to email@example.com Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE