What are the responsibilities and job description for the Director, Clinical Pharmacology position at SciPro?
SciPro is working alongside the Clinical Development Leadership team for an exciting oncology company based in New Jersey and New York. The biotech has received over $340M Series D funding and is significantly ramping up its clinical development function with a Director, Clinical Pharmacology to build their modeling and simulation function.
The role involves conducting advanced modeling and simulation tasks, including nonlinear mixed-effects analysis, population pharmacokinetics/pharmacodynamics, disease progression modeling, statistical and physiologically based pharmacokinetics, allometric scaling, quantitative systems pharmacology, clinical trial simulations, meta-analyses, and applications of machine learning and deep learning.
The individual will assist Clinical Pharmacology Leads in leveraging quantitative methodologies to characterize drug exposure-response relationships and provide data-driven justification for initial human dosing, recommended Phase 2 dose, and final labeled dose in regulatory discussions.
Backed by a leadership team of a Nobel prize winner, and former leaders from globally renowned pharmaceutical companies - the management team values pharma training as they have an incredibly high pedigree!
Responsiblies include but are limited to:
- Assist Clinical Pharmacology Leads in evaluating data from preclinical, clinical, and independent pharmacology studies.
- Apply both fundamental and advanced modeling and simulation strategies to perform thorough exposure-response assessments.
- Develop and analyze pharmacokinetic/pharmacodynamic (PK/PD) models to guide dose selection and optimize dosing regimens.
- Implement various scaling methodologies to design appropriate dosing strategies for first-in-human trials and special populations, such as pediatrics.
- Analyze biopharmaceutics data, including dissolution performance, to bridge in vitro formulation characteristics with in vivo outcomes in humans.
- Independently plan, execute, and report modeling and simulation activities, effectively communicating findings to support strategic decision-making.
Requirements include:
- Advanced degree with 10 years of experience or a Bachelor's degree with 12 years of experience in Pharmacology, Pharmaceutical Sciences, or a related discipline.
- Proficiency in PK/PD modeling software such as NONMEM, R, SAS, MATLAB, Phoenix, SimCyp, GastroPlus, etc., is essential.
- Expertise in quantitative pharmacology, with extensive hands-on experience in modeling and simulation to support dose selection, safety assessment, and product labeling.
Salary : $240,000 - $260,000
