Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 29, 2024

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 DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as an Associate Director, Quantitative Clinical Pharmacology Lead in Cambridge, MA, where you will lead strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. You will serve as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.Our Data Sciences Institute (DSI) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.As part of DSI, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project.How you will contribute: -

• Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
• Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum.
• Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
• Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.
• Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
• Oversees and/or independently performs PK, PD, and 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.
• Participates as a member of Business Development due diligence, when requested.
• Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives.
• Possess primary responsibility for dosage selection and generation of causality evidence.
• Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
• Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.Minimum Requirements/Qualifications:
  • Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD.
  • MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.
  • Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies.
  • Formulates and executes clinical pharmacology plans including integration of MIDD principles.
  • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.
  • Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA, EMA and others).
  • Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making.
  • Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics.
  • Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy.
  • Independently works by delivering, and prioritizing QCP activities across projects with minimal supervision. -
  • Effectively drives and influences project teams towards objectives while enabling and making decisions.
  • Focuses on priorities and delivers on commitments.
  • Strong communication skills and ability to translate effectively across functional lines.
  • Possess collaborative mindset, inspire teamwork, and is effective at building alliance across functions.
  • Assess benefit/risk of options.
  • Develop understanding of business beyond QCP/Pharmacometrics.More About Us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "remote" by Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. -For Location:Boston, MAU.S. Base Salary Range:$149,100.00 - $234,300.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.---The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. -U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. -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

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