・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑English language required
☑Japanese language required
☑Hybrid (On-site x Remote)
Associate Director, Non-Clinical and Clinical Pharmacology/臨床薬理
Global pharmaceutical company
This is what you will do:
The Associate Director, Non-Clinical and Clinical Pharmacology (NCCP) is responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. The incumbent will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition the incumbent will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, the incumbent will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. The incumbent will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. The incumbent will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. The incumbent will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development.
You will be responsible for:
- Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, Bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, M&S plans
- Contribute to the preparation of the pre-IND, IND, IB, IMPD and other Clin Pharm regulatory documents
- Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software
- Contribute to the design of early phase clinical trials (FIH to POC) and support project goals
- Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling
- Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC
- Contribute to the design of late-stage clinical trials (POC-BLA/NDA) and support project goals
- Responsible for leading the justification and recommendation for the dose(s) in Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies.
- Responsible for the preparation of the PK/PD reports and clinical study reports
- Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings.
- Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions.
You will need to have:
- Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant discipline.
- From 5-10 years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry.
- Hands on experience in small molecule drug development that covers the areas of DMPK, Clinical Pharmacology and posology is must. Pertinent experience in early and late stage biologics drug development and knowledge of clinical immunology is highly desired.
- Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data
- Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA, EMA or PMDA
- Excellent written and oral communication skills including good presentation skills
We would prefer for you to have:
- Foundational academic training in Pharmacokinetic/Pharmacodynamic/ Clinical Therapeutics
- Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software.
- Experience with performing allometric scaling and making prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials.
- Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports.
- Knowledge of current practices and issues in the bioanalytical and drug metabolism areas
- Proficient in the use of Microsoft Word, Excel and Powerpoint
- English Language level: Business level
- Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
- Work permission in Japan required
14~17 million JPY
Full 2 holiday week system (Sat/Sun) national holidays
New year's holiday
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider