PK Sciences project team representative developing pharmacology strategies for transformative new medicines. Collaborates in clinical development, providing insights on drug candidates and dosing strategies.
Responsibilities
Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate
Proactively contributes to developing drug candidates across Research Development and Commercial continuum, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input
Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions
Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development
Provide PK, dosage, and PK/PD components of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions
Drive close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), through PK science sub-teams.
Works in close collaboration with clinicians and clinical development colleagues to integrate PKS insights into study design, data interpretation, and project decision‑making
Use of Artificial intelligence (AI) / Machine Learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, authoring regulatory documents, and the use of predictive models
Requirements
Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
A minimum of 0-2 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).
2+ years of experience preferably in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development to be considered for Principal Scientist II.
Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation.
Experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
Exposure to working in a cross-functional, matrixed, project-team environment.
Strong oral and written communication skills.
Benefits
health, life and disability benefits
401(k) with company contribution and match
generous time off package including vacation, personal days, holidays and other leaves
Data Scientist collaborating with teams to optimize machine learning for advertising. Building and deploying models for campaign performance across e - commerce and social commerce platforms.
Postdoctoral Research Fellow in quantum technologies at MERL, shaping research agendas and publishing high - impact articles. Collaborative role with potential transition to full - time research staff.
Research Scientist specializing in optimization algorithms for electric grids, drones, transportation, and supply chain management. Aiming to impact the scientific community and Mitsubishi Electric's future technology.
Postdoctoral Research Fellow focusing on agentic AI systems at Mitsubishi Electric Research Laboratories. Engaging in independent research and collaborating with teams to publish findings.
Research Fellow in edge AI acceleration focusing on energy - efficient circuit design at Singapore University of Technology and Design. Engaging in software - hardware co - optimization and graph - based prediction applications.
Developing nuclear weapons effects simulations and modeling tools at Leidos. Engaging in radiation hydrodynamics with opportunities for telework and collaboration with senior staff.
Senior Principal Scientist / Associate Director at Novartis involved in developing and implementing translational pharmacology strategies. Driving interdisciplinary collaboration to support transformative new medicines.
Research Assistant conducting experiments and supporting innovation at Meissner in scientific research. Collaborating with R&D teams and maintaining meticulous records of experimental data.
Senior Principal Scientist focusing on cardiovascular translational development and late - stage clinical research at Bristol Myers Squibb. Integrates laboratory science and project management to maximize drug development potential.
Senior Research Scientist leading AI initiatives at GEICO, focusing on complex ML and GenAI solutions while mentoring teams and delivering business impact.