What are the responsibilities and job description for the Senior Scientist, Quantitative Pharmacology position at Alternative Resources Company?
Senior Scientist, Quantitative Pharmacology
The Quantitative Pharmacology group is responsible for the oversight over drug development aspects related to clinical pharmacology and pharmacometrics of clinical development candidates, working in close collaboration with nonclinical and clinical functional areas, and working with all therapeutic areas within the Development Division. Candidates must have a strong background in quantitative drug development and a desire to work collaboratively across different functional areas, as well as with external vendors and partners. Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group. To this end, the company strives to create an environment of mutual respect, encouragement and teamwork. As part of the global team, the individual will collaborate with talented and dedicated colleagues across the Development Division while developing and expanding their career.
Responsibilities
- Key member of a product development team, contributing to the advancement of novel chemical entities bringing a quantitative perspective into strategic development to support continued investment
- Development and execution of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include population pharmacokinetics, pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling, model-based meta-analysis, clinical trial design simulations, and quantitative systems pharmacology (QSP) modeling
- Drive the implementation of pharmacometric principles and practices
- Provide pharmacometric support for programs through the worldwide marketing application filing including supportive registration documents and presentations
- Provide clear, timely communication and interpretation of study results to functional area experts and governance/senior management
- Contribute to assessment of internal and external opportunities
- Interface broadly with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research
- Experience applying appropriate FDA, EMA, and ICH guidelines in the design of MIDD plans and analyses, and preparation of pharmacometrics components of regulatory submissions and inquiries.
- Mentor and/or supervise junior staff to perform above duties and support career development
Qualifications
- PhD in a quantitative science (e.g., statistics, mathematics, engineering, physics, computer science) or PharmD
- 4-8 years of postdoctoral experience in quantitative pharmacology/pharmacometrics in the biotech and/or pharmaceutical industry
- Prior experience in the development and application of quantitative methods in drug development
- Strong hands-on modeling and simulation skills using NONMEM, R, and/or other modeling and simulation software. Experience with population PK models, advanced mechanistic PK/PD models, disease models, PBPK models is highly preferred
- Proven track record in clinical research and background in biomedical research
- Demonstrated record of scientific scholarship and achievement, willingness to work collaboratively across different therapeutic areas.
- Strong interpersonal writing and presentation skills, as well as the ability to function in a team environment are essential
- Ability to thrive in a fast-paced business environment
