Work Your Magic with us Ready to explore break barriers and discover more We know you ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people s lives with our solutions in Healthcare Life Science and Electronics Together we dream big and are passionate about caring for our rich mix of people customers patients and planet That s why we are always looking for curious minds that see themselves imagining the unimaginable with us United As One for Patients our purpose in Healthcare is to help create improve and prolong lives We develop medicines intelligent devices and innovative technologies in therapeutic areas such as Oncology Neurology and Fertility Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life Joining our Healthcare team is becoming part of a diverse inclusive and flexible working culture presenting great opportunities for personal development and career advancement across the globe Scientific Director Clinical Pharmacology Scientific Director Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic scientific and cross-functional role leading the Clinical Pharmacology CP Expert Team responsible for developing and executing clinical pharmacology and Model Informed Drug Development MIDD strategies from the early to late-stage clinical development This role represents the CP Expert Team to the global cross functional drug discovery and development project teams in close collaboration with colleagues in Biostatistics Data Sciences Clinical Biomarkers and Diagnostics Research Clinical Development and other colleagues within the R D organization The CP Expert Team Lead provides strong leadership for integrating individual functional contributions developing clinical pharmacology strategy in alignment with the overall clinical development plan and executing the program strategy plan The scope includes programs from exploratory development ED through life cycle management encompassing large and small molecule therapeutics drug candidates across different therapeutic areas KEY ACCOUNTABILITIES Ensures that CP strategy is developed aligned with cross-functional development plans endorsed and executed to support the indication patient population and phase of development while taking into account the competitive landscape Represent clinical pharmacology and promote MIDD with internal and external stakeholders Provides in-depth CP PK and PK PD advice and expertise and lead clinical pharmacology expert team and deliver on Dose and posology decisions from FIH starting dose through submission and beyond Fit-for-purpose CP package including dose dose regimen and adjustment for specific conditions and specific populations exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development Develop and execute MIDD strategies plans in collaboration with pharmacometrics and other functions PK PD data analysis interpretation and presentation Related sections of major clinical and regulatory documents e g clinical protocols IBs CTDs INDs NDAs IMPDs briefing books Contribute to due diligence projects if needed EDUCATION LANGUAGES 7 years Bio pharmaceutical industry and or postdoctoral experiences with clinical drug development experience Doctorate degree PhD PharmD or MD relevant in the related disciplines of clinical pharmacology pharmaceutics pharmacometrics statistics engineering or mathematics Fluency in English PROFESSIONAL SKILLS EXPERIENCE Strong understanding of clinical drug development strategies and quality related requirements in drug development in GXP-related areas Deep knowledge in CP i e PK ADME posology quantitative translational sciences etc Excellent knowledge of regulatory requirements and submission across the main regions Good understanding about translational sciences such as quantitative pharmacology safety and biomarkers Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks General knowledge of oncology immuno-oncology and or immunology and more in depth understanding of biology and pharmacology is a plus Hands on modeling expertise is a plus Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix setting Demonstrated ability for productive collaboration in a multi-discipline team using effective communication and taking personal accountability for timely delivery of results Strong presentation communication and organization skills Ability to communicate technical results to stakeholders have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative strategic capabilities What we offer We are curious minds that come from a broad range of backgrounds perspectives and life experiences We believe that this variety drives excellence and innovation strengthening our ability to lead in science and technology We are committed to creating access and opportunities for all to develop and grow at your own pace Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity
📌 Edqy-0, Scientific Director Of Clinical Pharmacology (Telangana)
🏢 Merck
📍 Telangana
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