Associate Scientific Director, Translational Quantitative Pharmacology

2 days ago


india Merck Full time

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.PURPOSE OF THE ROLE The Associate Scientific Director, Translational Quantitative Pharmacology (TQP) position in Quantitative Pharmacology (QP) within the broader Clinical Measurement Sciences (CMS) organization is a scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) strategies across the R&D lifecycle.This position will be responsible for all TQP assignments either executed internally or in collaboration with external TQP related CROs by providing close scientific and technical supervision. The incumbent will be expected to manage multiple projects simultaneously and participate in discussions and presentations.The role requires the candidate toalso communicate TQP related science and strategies to all interfacing disciplines at the project or non-project levelsand help develop modeling toolboxes to assist  project teams in making quantitatively-driven decisions.SPECIFIC JOB DESCRIPTIONKEY ACCOUNTABILITIESTo be an independent contributor in the field of translational quantitative pharmacology to help advance the fundamental science of the field, to help guide, educate, mentor and contribute to the success of the discipline within the company.To be able to independently develop quantitative mechanism-based PK/PD models that will inform compound progression decisions from lead optimization to clinical proof of concept and beyond for the immunology and oncology pipelines for all modalities of interest.The incumbent will have responsibilities for performing human PK predictions and quantitative DDI predictions, the design and analysis of pre-clinical PK/PD experiments and data to support preclinical development, and translational PK/PD analyses to support FIM dose estimates for all modalities of interest.The incumbent will work to develop models or use commercially available software tools to understand and quantify toxicological signals such as cardiovascular, hepatic, renal, dermal etc to determine the therapeutic index and help guide project decisionsTo be able to interact with various project team members in a clear and timely manner, understanding the functions of other team members and being able to explain and educate model-based analyses and results to team members from various backgroundsThe incumbent candidate will work in a dynamic team with frequent interactions, both within the team and with associated functions, and will be responsible for the development and implementation of innovative modeling and simulation platforms/strategy that ensure that the right drug is administered to the right patient at the right dosage.As a member of project teams and sub-teams, the incumbent will represent QP and present analysis outcomes to cross-functional teams, at department meetings, project review committees and conferences.The candidate will contribute to the preparation and presentation of both internal and external documentation (e.g. Investigator's Brochure, IND, CTD) and program strategy.STRATEGIC IMPACTProvide technical expertise to promote and deliver on MIDD strategy of the QP organizationCOOPERATIONInterfaces with other Departments/Functions:Oncology and Neurology & Immunology Research UnitsClinical Pharmacology (CP)BiostatisticsSafety Sciences (Toxicology)DMPKBiomarkersPharmacometricsData SciencesProject TeamsExternal Interfaces:Represent company/ organization in consortia (e.g. IQ working groups) and academic research partnerships.Represent function and department in interactions with contractorsPresent and publish work in relevant journals and MIDD related conferences.CANDIDATE'S PROFILEQualifications, Experience, Knowledge & Competencies:EDUCATION/LANGUAGESA minimum of 5 years in industry and/or academia in a relevant backgroundA PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical/Chemical Engineering, Applied Mathematics, or a related discipline with a proven track record of applying modeling and simulation approaches to biological problemsFluency in English.PROFESSIONAL SKILLS & EXPERIENCESound knowledge of the theory and principles of Quantitative Systems Pharmacology plus hands-on competence in mathematical modeling of pharmacologic effects with mechanism-based models using relevant software or programming languages (e.g., MATLAB/SimBiology, NONMEM, R, Monolix).Experience in applying translational PK/PD M&S including QSP approaches in research and early clinical development to inform confidence in target/ mechanism, dose/ regimen, and combinations.Knowledge of basic principles of biology and pharmacology at the organismal, cellular and molecular level, preferably in one or more of the following areas: oncology, immuno-oncology, immunologyAbility to rapidly assimilate knowledge of complex biology of drug action for novel mechanisms and transform such understanding into multi-scale mathematical models, with requisite mathematical and computational proficiencyExperience in applying PBPK modeling and simulation using relevant software (e.g., MATLAB, Simcyp, GastroPlus) is desirable.Experience with toxicological predictions using tools such as DILI Sym/RenaSym for hepatic and renal toxicity respectively is highly desirableAbility to mentor, educate and explain modeling concepts and approaches to colleagues within QP/CMS and the larger organization as wellFlexibility and keen pursuit of innovation throughout all phases of the drug discovery and development processA desire to develop and grow by way of taking responsibility and engaging in additional tasks and operations.Ability to work independently and deliver results in a timely mannerPublications in conference proceedings and peer-reviewed journals is desirableExcellent communication skills with the ability to translate and summarize outcomes of modeling and simulation analysis as relevant for research and development projectsWhat 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 progressApply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity



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