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Clinical and Quantitative Pharmacology Lead

Company: Takeda Pharmaceutical
Location: Dumont
Posted on: November 17, 2021

Job Description:

By clicking the -Apply- button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAs a Clinical and Quantitative Pharmacology lead in Cell Therapies, you will support the development of these novel therapeutic modalities from early phase to late phase and regulatory submission. Develop clinical pharmacology strategies, execute clinical pharmacology studies, and perform dose-exposure-response analyses within the context of multi-scale, physiologic systems in the cell therapy context. Lead the implementation of model based analysis and be responsible for supporting dose and regimen recommendations, identification of patient and product related factors that impact efficacy and safety, and other clinical and regulatory support for Takeda's cell therapy programs. This individual demonstrates significant knowledge of -translation and clinical pharmacology, pharmacometrics based modeling to establish quantitative relationship between cellular kinetics & response (safety, efficacy, biomarker), address product development questions and contribute to clinical pharmacology package. The position's objectives also include comprehensive understanding and interpretation of preclinical packages, protocol development, data interpretation, study report completion, and communication of results with recommendations on future development decisions.This position will be part of Cell Therapy Clinical Pharmacology, Modeling & Bioinformatics group within Precision & Translational Medicine as part of Oncology Therapeutic Area Unit. All efforts will be directed toward progression of cell therapies into and through clinical development with the ultimate objective of global regulatory approval.-----------------------------------ACCOUNTABILITIES:-

  • This role will be expected to be the primary point of accountability at the asset level for assigned programs and will provide scientific, and quantitative input as the Clinical/Quantitative Pharmacology Lead on the Global Program Teams, and associated scientific and operational sub-teams.
  • Leads dose justification, reinfusion strategy, CK/PD based assessments, immunogenicity by integrating cellular kinetics, pharmacodynamics, product and patient characteristics throughout clinical development in close collaboration with key functions.
  • Responsible for the design and implementation of the quantitative Pharmacology plans using traditional and model informed drug development approaches and will manage the clinical study process from protocol development to final study reporting.
  • Responsible for the leading, planning or execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta analysis, and decision analysis supporting cell therapy projects.
  • Closely collaborate with functional leads from clinical, translational, stats, discovery, manufacturing and regulatory to ensure modeling is performed to address critical clinical questions in a timely and efficient manner.
  • During the pre-clinical stages of product development works with research teams to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge to justify human dose and route of- administration.
  • Provide input to optimize in vitro & preclinical CKPD data supporting the dose & advancement of programs into clinical development and the submission of Investigational New Drug applications. Perform reverse translation of cellular kinetic and competitors data to influence project/product decisions.
  • Develop CPAP (clin pharm analysis plan) and exposure response modeling plans in collaboration with key stakeholders to address program & regulatory questions (EOP1/2, BLA)- integrating patient and product related data.
  • Conduct or oversee non-compartmental analysis (NCA), cellular kinetic (CK)/pharmacodynamic (PD) and dose-exposure-response analyses to support dose selection and trial design at all stages of drug development, internal go/no decision-making, regulatory submission documents, and publications. Example approaches include logistic regression, miultivariate analysis,- binary and categorical data analyses, time-to-event (hazard) models, Poisson models, MCMC and Bayesian methods.
  • Lead and conduct reverse translation of cellular kinetic and competitors data to influence project/product decisions.
  • Manage program timelines for clinical pharmacology components and related matters; manage budgets to meet or exceed time, quality, and fiscal objectives.
  • Align with the project and analytics team (statistics, data management, database programming, programming, medical and scientific writing) on the pharmacometric strategy, execution and delivery of assigned projects.
  • Responsible for clinical pharmacology contributions to all regulatory documents including Investigator Brochures, protocols, pre IND, EOP1/2 and BLA meetings. Takes a lead role in writing and reviewing responses to pharmacology queries from regulatory agencies.
  • Stay abreast of literature, regulatory guidelines, and internal guidance as relates to pharmacometrics and MIDD.
  • Mentor and coach junior staff, promoting Takeda's values and behaviorsEducation:-
    • PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other disciplines related to quantitative pharmacologyRequired:-
      • Clinical pharmacology/modeling experience in the pharmaceutical/ biotechnology industry covering early to late phase clinical development.
      • Experience with and/or strong interest in Cell Therapy, Oncology or- Immuno-oncology
      • Ability to apply pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, including modeling and simulation to clinical trial design, and address clinical & product related questions.
      • Demonstrated expertise in the design, analysis and reporting of clinical pharmacology studies. The candidate must be competent in the use of industry-standard computational software for noncompartmental, physiological and multi-scale modeling, and Bayesian analyses and simulation.
      • Track record of publications and contributions to INDs, NDAs/BLAs, with various regulatory agencies & defending clinical pharmacology packages. Minimum of 5 years or more of strong experience in a quantitative field (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics). Job title is flexible based on experience.
      • Demonstrated expertise in pharmacometric analysis (popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses) and programming software (e.g., Nonmem, Monolix, R, SAS).
      • Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
      • Understanding of regulatory expectations on modeling analysis plan and reporting requirements.
      • Track record of publications and contributions to INDs, NDAs/BLAs, with various regulatory agencies & defending modeling plans for oncology programs.Knowledge and Skills:
        • Excellent written and verbal communication, organizational and interpersonal skills, be a strong team player and fully at ease in a matrix environment.
        • Ability to advance multiple projects in a fast paced -biotech like- environment; drive initiatives, lessons learned, and best practices
        • Ability to work in a demanding environment with aggressive project timelines
        • Demonstrated stakeholder management with strong influence/leadership-TRAVEL REQUIREMENTS:
          • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required
          • Requires approximately 10% travelAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.-WHAT TAKEDA CAN OFFER YOU:
            • 401(k) with company match and Annual Retirement Contribution Plan
            • Tuition reimbursement Company match of charitable contributions
            • Health & Wellness programs including onsite flu shots and health screenings
            • Generous time off for vacation and the option to purchase additional vacation days
            • Community Outreach Programs
            • Empowering Our People to Shine-Discover more at takedajobs.com#LI-KD1This job posting excludes CO applicants.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Yonkers , Clinical and Quantitative Pharmacology Lead, Healthcare , Dumont, New York

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