Manager, Clinical Pharmacology & Pharmacometrics

BeiGene • San Carlos, CA

7d

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. 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. Essential Functions of the Job: 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-inhuman 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.

Requirements

• 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 WinNonlin or PK-NCA.
• 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.

Nice To Haves

• Experience with one or more of the following is preferred: NONMEM, Monolix, Berkeley Madonna, Simcyp, Gastroplus.

Responsibilities

• 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-inhuman testing to all phases of clinical development.
• 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Manager