Ambrx Inc. is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.
We are seeking a talented and motivated individual for the position of Director in Clinical Pharmacology & Pharmacometrics (CPP). In this role, you will function as a clinical pharmacology lead on project teams to drive the clinical pharmacology and model-informed drug development strategy for oncology and immune-oncology programs across all clinical development stages. In addition, you will apply clinical pharmacology knowledge to inform design of clinical pharmacology studies or clinical pharmacology component of clinical studies, conduct pharmacokinetics (PK) / pharmacodynamics (PD) analyses, and draft analysis reports.
- Representing CPP and providing subject matter expertise on cross-functional project teams
- Leading clinical pharmacology programs supporting clinical development for ADCs in oncology
- Developing CPP plan and content for interactions with health authorities
- Authoring/reviewing clinical protocols, analysis plans, study reports, and regulatory submissions (e.g., INDs, IBs, BLAs etc.)
- Performing pharmacometric analyses and drafting reports for population PK and exposure-response analyses
- Managing third-party vendors to ensure timely delivery of high-quality study reports
- PhD or equivalent degree in Clinical Pharmacology, PK, Pharmaceutical Sciences, Biomedical Engineering, or a related scientific discipline with 5+ years’ experience
- In-depth knowledge of PK, PD, and/or translational sciences.
- Hands-on experience with PK/PD analysis using software programs (e.g., WinNonlin, NONMEM, R etc.)
- Good oral and written communication skills and ability to convey analysis findings clearly
- Ability to assess, prioritize and manage a diverse, time-sensitive workload
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code. 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.