Senior Scientific Director, Modeling and Simulation

Company: Takeda Pharmaceutical
Location: Hempstead
Posted on: November 12, 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 DescriptionSenior Scientific Director, Modeling and Simulation Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientific Director, Modeling and Simulation in our Cambridge, MA office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.As a Senior Scientific Director, Modeling and Simulation working on the Quantitative Solutions -team, you will be empowered to provides scientific leadership and high value modelling and simulation strategies to support Takeda programs as a member of the QS team and PTS organization by collaborating with DDU functions.- A typical day will include:POSITION OBJECTIVES:

• Provides general scientific leadership and high value modelling and simulation strategies to support Takeda programs as a member of the QS team and PTS organization by collaborating with DDU functions, Global Clinical Development Teams (GCDT), Experimental Medicine, Therapeutic Area teams, and other relevant functional areas.
• Responsible for impactful strategic scientific input and modeling and simulation (M&S) technical expertise throughout the drug development lifecycle.
• Must possess the scientific, interpersonal, managerial, and strong communication skills to understand, conduct, and deliver the outcome of complex translational research, and M&S programs utilizing both internal and external resources. Serves as a senior member and mentor for QS, PTS and R&D demonstrating impact and value of model based approaches during drug development.
• Ensures quantitative methodologies are implemented and completed in a timely manner to enable impactful and high quality decision making.POSITION ACCOUNTABILITIES:
  • Responsible for input on design and incorporation of M&S components within a scientifically sound quantitative development plans and clinical study protocols.
  • Actively participates and provides mechanistic, empirical and quantitative systems pharmacology (QSP) modelling support in design of preclinical and clinical studies with M&S components which may include data analysis and interpretation.
  • Conducts complex modelling and simulation exercises using appropriate tools/software for the quantitative analysis task and maintains in depth knowledge of mechanistic, complex PK-PD modelling, systems pharmacology, clinical utility index modelling and model based meta-analysis. Working knowledge of machine learning and AI is highly desirable.
  • Manages emerging problems or issues relevant to M&S activities while keeping leadership informed of critical issues in a timely manner.
  • Maintains high level of competence as a user of computational platforms such as NONMEM, MONOLIX, Phoenix, Berkeley Madonna, GastroPlus, SimCyp and/or MatLab. Maintains competency in use of data management tools such as R or S-Plus and has working familiarity with Shiny or R-Studio.
  • Responsible for preparing, reviewing, and/or approval of sections of global regulatory filings relevant to preclinical and clinical modeling and simulation activities of assigned compounds including: Investigational New Drug Applications (IND), Regulatory Briefing Documents, Investigational Brochures (IB), Investigational Medicinal Product Dossiers (IMPD), Common Technical Documents (CTD) as the basis for New Drug Applications (NDA) in the U.S. and Market Authorization Applications (MAA) in the EU, IND annual reports, EMA/CHMP documents, and scientific white papers. Point of contact for QCP-QS SOP and policy development.
  • Represents QS and Takeda in meetings with regulatory agencies and health authorities if needed.
  • Provides mentoring in modeling and simulation to new staffs and members of other functional areas and collaboratively interacts with scientists from other functional areas, divisions, affiliates and alliance partners.
  • Represents Takeda at external meetings and conferences as well as establish the reputation of Takeda with the external experts and medical community.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • Ph.D. or equivalent higher degree +15 years of pharmacometrics, clinical pharmacology, pharmacokinetic, DMPK, relevant engineering fields, applied biomathematics, bioengineering or other relevant experience is preferred
    • Educational degree in a relevant scientific area, e.g., Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, Bioengineering, Mathematics, etc.
    • Significant drug development experience from a modelling and simulation, DMPK, clinical pharmacology, perspective is required.
    • In depth, expert knowledge of mechanistic and QSP modelling, pharmacometrics, pharmacokinetics and pharmacodynamics, -including PK/PD data analysis and modelling techniques as well as interpretation of complex data and statistical analyses.
    • Proficiency in R language and familiarity with scripting is highly desirable-
    • Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science.
    • Must have scientific and technical expertise as evidenced by publications, patents, awards/honors and credibility at professional societies.- Alternatively, must have evidence of successful utilization of scientific and technical principles in negotiation of project goals with internal management and/or regulatory agencies.
    • Thorough understanding of drug development and global regulatory requirements.Takeda U.S. Vaccine Requirement:Absent 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.This job posting exclude Colorado applicants.TRAVEL REQUIREMENTS:
      • Access to transportation to attend various meetings held in proximity to the Takeda offices.
      • Able to fly to various meetings at investigator, vendor or regulatory agency sites.
      • Some international travel may be requiredWHAT 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.*RM-LIEEO 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, Hempstead , Senior Scientific Director, Modeling and Simulation, Executive , Hempstead, New York