- Develop clinical pharmacology plans and contribute to regulatory submissions, including INDs, IBs, NDAs, MAAs
- Author, review, and approve clinical protocols, analysis plans, study reports and regulatory submissions
- Define and execute clinical pharmacology components of drug development programs, including planning, designing and oversight of clinical pharmacology studies
- Plan and execute clinical pharmacokinetic and pharmacodynamic analyses
- Serve as a project team representative, support project teams across multiple therapeutic areas, provide input on clinical pharmacology and biomarker studies and contribute to project teams.
- Lead application of pharmacometrics in translational and clinical development
- Apply quantitative approaches to develop and implement translational PK/PD strategies, application of biomarker strategies, inform dose and dosing regimen selection and support product development decisions.
- PhD, PharmD or MD with 3+ years experience in clinical pharmacology, pharmacokinetics, pharmaceutics, pharmacometrics, (bio)statistics, biomedical engineering, or a related discipline.
- Experience with population modeling and simulation software (e.g. NONMEM, Phoenix WinNonlin and NLME, S-Plus/R).
- Demonstrated success in executing clinical pharmacology programs and quantitative drug development (population and mechanistic PK/PD modeling and simulations)
- Knowledge of current and emerging scientific standards and regulatory requirements
- Excellent written and oral communication, interdisciplinary collaboration and problem-solving skills and ability to convey complex technical information
- Experience with successful regulatory filings (IND, NDA/BLA, MAA)
- Scientific excellence as demonstrated through track record of publications or presentations in clinical pharmacology and application of quantitative methods in drug development
- Experience in experimental study design, problem solving, critical data analysis and interpretation
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Director, Clinical Pharmacology - Newark, United States - Protagonist Therapeutics
1 week ago
Description
DIRECTOR CLINICAL, PHARMACOLOGY
The Director, Clinical Pharmacology, role is a critical function that will be responsible for leading the design, planning, and execution of clinical pharmacology programs.
The candidate will work closely with colleagues in clinical development, clinical operations, biometrics, discovery and other functions to execute translational and development programs.
The individual will support the implementation of model-informed drug discovery and development, including providing pharmacometrics strategy and quantitative rationale for safety margins, dose selection, patient selection and stratification.
Specific Responsibilities:
Requirements:
The base pay range for this position at commencement of employment is expected to be between $210,000 and $250,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform.
Protagonist and Janssen scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development.
Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program.
The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway.
The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.
