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Director - Pharmacokinetics & Clinical Pharmacology

Remote, CA, USA | ChemoCentryx

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    Biotech/R&D/Science
  • Experience:
    10-12 years
Job Description:
62 people have viewed this job

ChemoCentryx has an opening for the Director, Pharmacokinetics & Clinical 

Pharmacology position which is responsible for the planning, execution and interpretation of

pharmacokinetic & clinical pharmacology studies for all drug development projects of the 

company. This position will report to the Vice President – DMPK/Tox & ClinPharm and work 

out of our state-of-the-art corporate center in San Carlos, CA, or remotely.


Key Responsibilities 


- Project human PK properties and clinical efficacy dose for drug candidates in the 

candidate selection process, based on in vitro and preclinical DMPK data, biological 

target potency and animal pharmacology results;

- Plan and execute clinical pharmacology studies and model-informed drug development 

strategy via application of quantitative methods to integrate knowledge of nonclinical 

data, PK, PD / biomarker, patient characteristics, disease states and drug interactions to 

inform development strategies, support patient sub-population, dose and dosage regimen 

selection, and optimize study designs throughout drug development;

- Plan, perform, and/or provide oversight for appropriate analyses of preclinical-clinical 

translation, dose/exposure-response relationships, to guide dose regimen and optimize 

study design and overall drug development strategy;

- Interpretate results of PK and PK/PD analyses with respect to their impact on a 

development program and clinical use;

- Contribute to key regulatory documents (such as study reports and CTD modules) for 

regulatory submissions


Requirements


- PhD degree in pharmacokinetics, clinical pharmacology, biochemistry, or relevant 

biological sciences

- 10+ years of experience with pharmacokinetics and clinical pharmacology in the drug 

discovery or development environment

- Deep understanding of PK, PD, PK/PD, and translational medicine and their applications

in drug development

- Well informed with the current FDA / EMA / ICH guidances on DMPK and Clinical 

Pharmacology studies

- Expertise in designing clinical PK protocols, performing PK/PD analysis, and 

interpreting the impact of these results on the clinical program

- Experienced in advanced analysis methods (e.g., population analysis, PBPK) and 

modeling tools (e.g., NONMEM, R, Phoenix NLME, WinNonlin, Simcyp and 

GastroPlus)

- Track record of critical contributions to NDA and MAA filing


ChemoCentryx is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.


At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.


Effective September 1, 2021, ChemoCentryx requires all employees to be vaccinated against COVID-19. In accordance with ChemoCentryx's duty to provide and maintain a workplace that is free of known hazards, we adopted this requirement to safeguard the health and safety of our team members, candidates, contractors, and vendors.Any and all job offers will be contingent upon proof of vaccination or an approved exemption from the requirement due to medical or religious reasons.


As an equal opportunity employer, ChemoCentryx, Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws


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