What are the responsibilities and job description for the Manager, Clinical Pharmacology position at ADLAI NORTYE USA INC?
Company Overview:
We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work.
Position Overview:
The manager of clinical pharmacology 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.
Responsibilities:
- 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, modeling & simulation plans
- Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA 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-NDA/BLA) and support project goals
- Responsible for leading the dose selection for 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.
- Provide oversight to vendors and ensure high quality deliverables that meet study/project timelines
- Develop standard working procedures for operation and data analysis
Experience:
- 3 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.
- Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus.
- 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 and other health authorities.
- Excellent written and oral communication skills including good presentation skills.
Education:
- Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant life science discipline such as biology, immunology.
Knowledge, License or Certifications:
- Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software.
- Familiar with PK/PD concepts. principles and applications to support 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.
Travel:
- 20%.