Manager, Clinical Pharmacology & Pharmacometrics

General Description

We are seeking a highly motivated candidate to join our Clinical Pharmacology and Pharmacometrics (CPP) group. The successful candidate will be responsible for developing and executing clinical pharmacology strategies for small molecules and biologics assets in the company portfolio, either independently or by working closely with other clinical pharmacologists. She/He will provide clinical pharmacology expertise in characterizing the pharmacokinetics and absorption, distribution, elimination profiles;

dose selection justification; assessing drug/food interaction potential; characterizing QT prolongation potential. This will be accomplished by working in close partnership with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of pharmacokinetic and pharmacodynamic data.

• You will work with experienced colleagues in the CPP group on facilitating the following activities to support Exploratory Analyses, CSRs, Health Authority responses, or Marketing authorization/NDA/BLA submissions:
• Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in-human testing to all phases of clinical development. This will be accomplished working independently or in close collaboration with the lead clinical pharmacologists for the project.
• Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
• Contribute to the design and analysis of PK data from patient clinical studies.
• Perform population PK (PPK) analyses to quantify variability in drug exposure and identify important covariates.
• Conduct exposure–response (ER) analyses supporting dose selection and benefit–risk evaluation.
• Analyze, interpret, summarize and present data to internal project teams and to senior management.
• Assist in authoring relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.
• Provide clinical pharmacology reviews on business diligence activities.

• A PhD or M.S. in Pharmacokinetics, Pharmaceutical Sciences/Pharmacy, Biomedical Engineering, Bioinformatics, Data Sciences, Mathematics, or related STEM discipline.

• A PhD or M.S. with 4+ years relevant work experience.
• Proficiency in using R for data manipulation, visualization, and basic statistical analyses is required.
• Exposure to working with and manipulating large datasets.
• Hands-on experience in performing NCA using Phoenix Win Nonlin or PK-NCA.
• Experience with one or more of the following is preferred: NONMEM, Monolix, Berkeley Madonna, Simcyp, Gastroplus.
• Demonstrated commitment to problem solving and developing creative solutions.
• Detail oriented to ensure accuracy and thoroughness of work.
• Ability to multi-task.
• Ability to adapt to fast-moving timelines and quick turnaround times
• Strong written and oral communication skills.
• Strong drive to learn and apply emerging technologies such as AI, ML, or other tools to improve daily task efficiencies.

• N/A

• N/A

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $ - $ annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each…