Takeda · 1 day ago
Director, Quantitative Clinical Pharmacology Lead
Cambridge, MA
Full-time
Hybrid
Director/Executive
$174K/yr - $274K/yr
8+ years expTakeda is a patient-focused, innovation-driven company seeking a Director, Quantitative Clinical Pharmacology Lead in their Cambridge, MA office. The role involves leading strategic, scientific, and operational aspects of drug development projects, providing scientific leadership, and mentoring junior staff to promote scientific excellence.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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. Has 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 and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications
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 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 DQS 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
Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA
Qualification
Required
Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
MS with 12+ 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
Preferred
Preference will be given to candidates with experience in oncology drug development
Benefits
Short-term and/ or long-term incentives
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-07
Company data provided by crunchbase