Director, Clinical Pharmacology

(Job 2023-BN-11)

Ambrx (NASDAQ: AMAM) is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

Ambrx is seeking a highly motivated Director, Clinical Pharmacology to lead and actively contribute to the development and execution of clinical pharmacology and pharmacometrics strategies across the Ambrx portfolio; participates in the design of clinical and relevant non-clinical studies; and interprets, presents and reports clinical and non-clinical study results.

Primary Responsibilities:
The Director, Clinical Pharmacology ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Acts as the lead clinical pharmacologist for multiple clinical stage programs.
Leads, and actively contributes to, the development of overarching clinical pharmacology strategies from IND to NDA (or BLA) to support regulatory submissions.
Leads the development of, and implements, optimal dose-finding strategies to ensure safe and effective advancement of clinical programs, including FIH dose selection, dose escalation and dose recommendation for the phase II and registration trials.
Leads, and actively contributes to the design and execution of clinical pharmacology studies to evaluate PK in special populations.
Leads, and actively contributes to, the design and execution of clinical drug-drug interaction and food effect studies following regulatory guidance.
Drafts Investigator’s Brochures (IBs), eCTD modules, and clinical study protocols in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing professionals.
Leads and performs PK analyses in non-compartmental model for the drug and/or metabolites.
Contribute to population PK/PD analyses and integrates this knowledge into the overall clinical development strategy(ies).
Evaluates and selects Contract Research Organizations (CROs) and manages/actively oversees outsourced PK and PK/PD.
Coaches and mentors team members.

Job Requirements:

PhD in a relevant scientific discipline OR a PharmD and a minimum of 5+ years of progressively responsible experience in a pharmaceutical, biotechnology or related environment
Demonstrated understanding or, and experience applying, clinical pharmacology concepts.
Familiar with regulatory guidance especially for drug interaction studies.
Highly proficient in performing NCA PK analysis using Phoenix WinNonlin.
Demonstrated expertise in developing and executing drug metabolism and pharmacokinetics studies.
Experience with common population PK/PD modeling software packages (such as NONMEM)
Preferred experience with common modeling software
Demonstrate understanding of formulation and toxicology.
Experience managing multiple projects with competing priorities.
Demonstrated experience in writing study reports and regulatory documents.
Ability to influence without direct authority.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively. as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Excellent management and interpersonal skills.
Up to 10% travel
Experiences in Oncology

Pay Scale:

The pay scale for this position is annualized at: $210,000 to $250,000, commensurate with experience. We believe this to be the possible compensation range for this role at the time of this posting, and we may modify this pay scale in the future.

To be considered for this opportunity, please submit your resume/CV referencing the position code to careers@ambrx.com. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.