Research Investigator Clinical Pharmacology Early Development

HengRui USA is the US hub for our parent company Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. The product line includes antineoplastic drugs, angiomyocardiac drugs, surgical drugs, contrast agents and antibiotics. The pipeline across different therapeutic areas such as oncology, autoimmune, pain management, metabolics etc.

In HengRui USA, we recognize, appreciate, and reward our team's contributions; we emphasize our people's well-being. We want you to feel empowered to do your best work, in a place where you are respected, engaged, fulfilled, and developing!

Job Summary: With appropriate mentorship, the candidate will support both early and late-stage global development projects, including developing the clinical pharmacology plan, designing clinical pharmacology and clinical studies, establishing PK/PD plans, performing PK/PD modeling/simulation and model-based meta-analysis, interpreting and integrating results to inform drug development decisions, writing clinical pharmacology sections of the clinical study reports and regulatory submission documents (briefing book, NDA, MAA, etc.). The candidate will work closely with multidisciplinary teams including clinicians, statisticians, regulatory affair, and clinical operations colleagues.

Essential Job Functions:

• Depends on experience, may lead (Sr. investigator) or execute (investigator) clinical pharmacology, immunogenicity, pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates across all phases of clinical development.
• Represent the department in study teams and develop clinical pharmacology study designs and collaborate with key stakeholders to write study protocols, amendments, and reports.
• Contribute to the design and analysis of PK data from patient clinical studies.
• Conduct hands-on clinical PK NCA, population PK, PBPK or other pharmacometric data analysis.
• Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) and POC studies).
• Authorization of protocol, relevant sections in investigator brochure (IB), and clinical study report (CSR)
• Closely interacts with non-clinical and bioanalytical team members for on activities related to assay development, sample management, pharmacogenomics and biomarker development to design and execution of first-in-human, mass balance, drug-drug interaction and PoC studies.
• Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
• Analyze, interpret, summarize and present data to internal project teams.
• Lead or contribute to process related departmental initiatives.

Job Requirements:

Experience / Education

• A PhD, MD, PharmD or equivalent degree in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related quantitative discipline.
  • Investigator, 0-3 years of experience
  • Investigator, 3-5 years of experience

Knowledge / Skills / Abilities:

• Knowledge of how Clinical Pharmacology can impact the overall drug development.
• Understanding of PK, PD, PK/PD, and Translational Medicine. Ability to interpret PK and PK/PD results and prepare presentations to illustrate findings accurately.
• Excellent communication skills, both written and oral, in order to deliver high quality protocols, regulatory documents, documents for team and management review, scientific manuscripts & posters for publication.
• Hands-on or good knowledge of with quantitative approaches in drug development, working knowledge of relevant modeling software (eg. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses. Familiarity with clinical study design options, especially for phase 1 and 2 studies.
• Working knowledge of statistical approaches as they apply to clinical study design & analysis.
• A good knowledge of GCP and working knowledge of relevant regulatory guidelines.

• Flexibility to react rapidly to changing situations/environment.

• Ability to travel up to 20% as needed.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability