Associate Director, Quantitative Clinical Pharmacology (Qcp) Lead

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, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Quantitative Clinical Pharmacology Lead 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.
OBJECTIVES: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
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 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.
Leads 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. Possesses 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.Serves 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.ACCOUNTABILITIES: 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.Integrates pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum.Drafts and executes 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 to inform internal decisions and external regulatory interactions.Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and is 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.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.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education & Experience: Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PDMS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PDDesired technical skills: 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.Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions.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.Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy.Desired behavioral competencies: 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 alliances across functions.Assess benefit/risk of options.Develop understanding of business beyond QCP/Pharmacometrics.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please.
#LI-JV2
Takeda Compensation and Benefits Summary We 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, MA
U.S. Base Salary Range: $149,100.00 - $234,300.00
The 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.
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.
EEO Statement: Takeda 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, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time

#J-18808-Ljbffr