Director, Clinical Pharmacology and 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:The Director, Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology and modeling & simulation strategies for small molecules and biologics assets in the company portfolio. She/He will provide clinical pharmacology & pharmacometric expertise in characterizing the pharmacokinetics profiles; dose selection justification; characterizing QT prolongation potential etc. This will be accomplished by working in close partnership with internal Clinical Pharmacology and Pharmacometrics members as well as cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of pharmacokinetic and pharmacodynamic data; as well as authoring and defending the Clinical Pharmacology sections of regulatory filings.As we are a growing team, we are flexible on role leveling. As such, candidates presenting skills at more senior or junior levels will be considered as well.Essential Functions of the job: Lead clinical pharmacology or pharmacometric activities on project teams.Lead AI and automation initiatives for clinical pharmacology and pharmacometrics deliverables.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 through 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.Conduct hands-on clinical PK, population PK and exposure-response data analysis.Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.Discuss clinical pharmacology & pharmacometric plans to support development and filings with health authorities.Author, review, and finalize 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 & pharmacometrics reviews on business diligence activities.Supervisory Responsibilities: Mentoring junior members of the group as neededManage clinical pharmacology vendors, consultants for specific project needsEducation Required: Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacometrics, Biomedical Engineering or related discipline with 5+ years of relevant experience. ComputerSkills: Proficiency with NONMEM/Monolix and R/S-Plus preferred.OtherQualifications: A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least four years of industry and/or related post- doctoral experience is preferred. Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings, hands-on modeling & simulation experience and/or publications are essential. Prior experience in AI/automation of clinical pharmacology and pharmacometrics preferred. Travel: Ability to travel to manage clinical pharmacology collaborations and to health authority interactions within and outside the USGlobal CompetenciesWhen 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range: $174,000.00 - $234,000.00 annuallyBeOne 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