Full-time

BeOne is hiring a Manager, Clinical Pharmacology & Pharmacometrics

About the Role

BeOne is seeking a highly motivated Manager, Clinical Pharmacology & Pharmacometrics to join our CPP group. In this role, you will be responsible for developing and executing clinical pharmacology strategies for small molecules and biologics assets in our portfolio, working independently or collaboratively with other clinical pharmacologists.

What You'll Do

  • Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of drug candidates from pre-IND through all phases.
  • Design clinical pharmacology studies and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports.
  • 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 senior management.
  • Assist in authoring relevant sections of regulatory filings (IND/CTA, NDA/MAA/BLA) and respond to health authority questions.
  • Provide clinical pharmacology reviews on business diligence activities.

What We're Looking For

  • A PhD or M.S. in Pharmacokinetics, Pharmaceutical Sciences/Pharmacy, Biomedical Engineering, Bioinformatics, Data Sciences, Mathematics, or a related STEM discipline.
  • A PhD or M.S. with 4+ years of relevant work experience.
  • Proficiency in using R for data manipulation, visualization, and basic statistical analyses.
  • 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 and 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 Have

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

Technical Stack

  • R, Phoenix WinNonlin, PK-NCA, NONMEM, Monolix, Berkeley Madonna, Simcyp, Gastroplus

Benefits & Compensation

  • Compensation: $120,100.00 - $160,100.00 annually + equity: Eligible for discretionary equity awards.
  • Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
  • Eligibility for annual bonus plan (Non-Commercial roles) or incentive compensation plan (Commercial roles).
  • Eligibility for discretionary equity awards.
  • Eligibility to voluntarily participate in the Employee Stock Purchase Plan.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

Required Skills
RPhoenix WinNonlinPK-NCANONMEMMonolixBerkeley MadonnaSimcypGastroplusClinical PharmacologyPharmacometricsPK/PD ModelingRegulatory SubmissionsStudy DesignMentoring
Planning long-term in Thailand?

Full relocation support, start to finish

From visa strategy to housing, banking, and schools for your family — SVBL plans and manages every detail of your move to Thailand so nothing falls through the cracks.

Complete relocation planning
Family visa & school enrollment
Banking & insurance setup
Cultural integration support
Plan your move
One partner for everything
About company
BeOne

BeOne is a company passionate about fighting cancer.

Visit website
Job Details
Category data
Posted a month ago