Director, Clinical Pharmacology and Pharmacometrics

Employer
Ambrx, Inc.
Location
La Jolla, CA, United States
Posted
Oct 15, 2020
Ref
-23-20BA
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Ambrx®, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein
therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create
a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with
proprietary linkers, payloads and pharmacokinetic extenders to create a single molecular species that
is optimized for safety, efficacy and biophysical properties. We call this process Protein Medicinal
Chemistry™.

Job Description:

This role, reports to Chief Medical Officer, plays essentials roles in clinical pharmacology & pharmacometrics, in addition to lead effectively in the cross-functional matrix team. The Director of Clinical Pharmacology & Pharmacometrics should have strong clinical pharmacology and quantitative analysis skillsets, create the model-based drug development plan, design, conduct, and interpret clinical studies, represent the CP&P function on study and project teams, and participate in and contribute to regulatory meetings.

Responsibilities
• Establish clinical pharmacology and pharmacometrices strategy to support clinical development programs.
• Represent the CP&P function on cross-functional drug development teams, contribute to design drug development strategies, regulatory submissions, and participate in interactions with health authorities.
• Work closely with translational and clinical teams, perform PK and PK / PD analyses using a variety of tools and approaches.
• Accountable for design and implementation of quantitative/clinical modeling and simulation strategy to interpret clinical results.
• Plan, execute, and report on model-based pharmacokinetic and exposure-response analyses of data from clinical studies
• Supervise and mentor if needed

Qualifications
• A PhD or PharmD in pharmaceutical sciences or relevant discipline with 5+ years of experience in pharmaceutical or biotech industry.
• Demonstrated experience in clinical pharmacology and pharmacometrices to support clinical stage programs.
• Demonstrated knowledge and experiences in modeling and simulation approaches to enable rational of clinical development.
• Strong written and oral communication skills necessary to report on and deliver scientific presentations.

To be considered as an applicant, please submit your resume/CV referencing the specific position of
interest and position code to careers@ambrx.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.