Clinical Pharmacology & Pharmacometrics openings at BeiGene

Dear all, We have a couple of open positions in our growing Clinical pharmacology group at BeiGene. The job description is posted below. Click the following link to apply directly. https://beigene.wd5.myworkdayjobs.com/en-US/BeiGene/job/San-Mateo/Associate-Director--Clinical-Pharmacology_R5567 - BeiGene 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. *Associate Director, Clinical Pharmacology* General Description: The Associate Director (AD), Clinical Pharmacology will be responsible for developing and executing clinical pharmacology strategies for small molecules and biologics assets in our oncology portfolio. The AD is expected to have a strong scientific background, excellent collaborative and communication skills and apply quantitative methodologies to inform decision making across all phases of clinical development. Essential Functions of the job: - Develop and execute clinical pharmacology, immunogenicity and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates across all phases of clinical development. - Represent Clinical Pharmacology function in cross-functional teams and provide subject matter expertise to inform relevant strategic decisions. - Develop clinical pharmacology study designs and collaborate with key stakeholders to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines - Plan and conduct hands-on clinical PK, pharmacometric data analysis and report the results of such analyses - Author relevant documents for regulatory submissions, including NDAs, BLAs, MAAs. Actively contribute to regulatory meetings and respond to questions from health authorities - Contribute to the design and analysis of PK data from patient clinical studies. - Analyze, interpret, summarize, and present data to internal project teams and to senior management. - Provide clinical pharmacology reviews on business diligence activities. Computer Skills: Hands-on experience in performing NCA using Phoenix WinNonlin is essential. Experience with one or more of the following is preferred: NONMEM, R, S-Plus, Berkeley Madonna, Simcyp, Gastroplus etc. For an Associate Director role with Pharmacometrics focus, hands-on experience with NONMEM and R is essential. Other Qualifications: A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least six years of industry and/or related post-doctoral experience is preferred. Demonstrable scientific and clinical development based on publications and/or strong references is essential. Prior experience with NDA/BLA/MAA filings or a good understanding of global health authority guidances and filing requirements is desired. Familiarity with DMPK studies and bioanalytical methods is preferred. Education Required: Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacometrics, Biomedical Engineering or related discipline Travel: Ability to travel to manage clinical pharmacology collaborations and to health authority interactions within and outside the US