Associate Scientific Director/Scientific Director, Pharmacometrics - Quantitative Clinical Pharmacol

Company: Takeda Pharmaceutical
Location: Livonia
Posted on: November 22, 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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.-- - Join us as an Associate Scientific Director/Scientific Director, Pharmacometrics,-- -Quantitative Clinical Pharmacology in our Cambridge office.-- - Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology working on the team, you will be empowered to manage strategic, scientific and operational aspects of multiple drug development programs from the clinical pharmacology perspective, and a typical day will include:-- -POSITION OBJECTIVES:The-- -Associate-- -Scientific Director/Scientific Director -- -leads key scientific, strategic, and implementation aspects of pharmacometrics across the Takeda R&D portfolioServes as a key subject matter expert on aspects of modeling and simulation for assets across phases 1-IV of development. Works closely with functional experts across the R&D organization such as: Research, Biostatistics, Regulatory Affairs, preclinical translational Sciences, Pharm Sci and Clinical Science, providing leadership and guidanceAssists in departmental management through program reviews and collaborative decision-making.ACCOUNTABILITIES:Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated scientific and operational sub-teams.Charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum.Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., SQS, QS and DMPK). Ensures that M&S (Modeling and Simulation) -- -plans are fully integrated with the larger program development plans to enable impactful Model-Informed Drug Development (MIDD) practices.Works closely with colleagues in DSI, QS, and with external partners to ensure advanced modeling and simulation approaches (e.g., QSP, MBMA) inform internal decisions and external regulatory interactions.Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.Responsible for clinical pharmacology summary documents for regulatory submissions (such as IB, CTA, CTD Module 2 documents, product labeling).Oversees and/or independently performs pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.Maintains a high standard for good clinical practice, compliance and ethics.Mentors junior staff to promote scientific excellence and individual achievement.Represents Clinical Pharmacology in meetings with global regulatory agencies for assigned programs.Participates as a member of Business Development due diligence, when requested.Leads infrastructure initiatives and/ or cross-functional best practice initiatives.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:-- -Associate Scientific Director Level: Ph.D or Pharm D. w/ 10+ years or M.S. w/ +12 years or B.S. w/ +15 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.Scientific Director Level: Ph.D w/ or Pharm D. w/ 12+ years or M.S. w/ 14+ years or B.S. w/ 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.Location and Salary Information: This job posting excludes CO applicants.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.WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to ShineLearn more at .No Phone Calls or Recruiters Please.#LI-JV2EEO 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, Rochester , Associate Scientific Director/Scientific Director, Pharmacometrics - Quantitative Clinical Pharmacol, Healthcare , Livonia, New York