Manager, Clinical Pharmacology & Pharmacometrics

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.

Please note the preference for this role is a San Francisco Bay Area location with a hybrid work scheudle of at least Wednesdays in the San Carlos, CA office.

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.

Education Required:

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

Qualifications:    

• 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.
• 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.

Supervisory Responsibilities:  

• N/A

Travel: 

• N/A

Global Competencies

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: $120,100.00 - $160,100.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the 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. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.