Director, Quantitative Clinical Pharmacology Lead
Location: Cambridge, Massachusetts
Job Type: Full-time, Regular
Department: Quantitative Clinical Pharmacology / R&D
Work Type: Hybrid (per Takeda’s policy)
Travel: Minimal
Compensation Range: $174,500 – $274,230 (depending on experience and location)
Employer: Takeda
Job ID: R0148595
Date Posted: April 3, 2025
Company Overview
Takeda is a global biopharmaceutical leader driven by R&D excellence and over two centuries of heritage. With a mission to deliver better health and a brighter future, Takeda empowers its workforce to drive transformative therapies across therapeutic areas including oncology, neuroscience, and rare diseases.
Job Summary
The Director, Quantitative Clinical Pharmacology (QCP) Lead will guide the clinical pharmacology strategy across multiple programs from first-in-human through lifecycle management. The role integrates model-informed drug development (MIDD) strategies, oversees pharmacometric and PK/PD analyses, and interfaces cross-functionally with regulatory, clinical, digital health, and data science experts.
Key Responsibilities
Serve as Global/Regional Clinical Pharmacology Lead for multiple projects.
Develop and implement Clinical Pharmacology plans integrated with modeling and simulation (e.g., QSP, MBMA).
Guide dose selection and exposure-response strategies using MIDD.
Represent Takeda in global regulatory agency meetings and contribute to submission documents.
Collaborate across functions (Pharmacometrics, DMPK, Biostatistics, etc.) to support strategic decisions.
Interpret PK/PD data and perform or supervise pharmacometric analyses.
Contribute to talent development by mentoring junior QCP staff.
Represent Takeda at scientific forums, regulatory workshops, and professional societies (e.g., ASCPT, PAGE).
Support business development through due diligence efforts.
Required Qualifications
Education:
PharmD or PhD in a quantitative field with 8+ years of relevant experience, OR
MS with 12+ years’ experience in quantitative pharmacology or related field.
Experience:
Advanced understanding of clinical pharmacology across early and late-stage development.
Experience with regulatory submissions and global regulatory agency interactions.
Strong track record in dose optimization, modeling, and application of MIDD principles.
Preferred: Oncology drug development experience.
Skills & Competencies
Expertise in PK/PD integration and cross-functional project leadership.
In-depth knowledge of FDA/EMA/ICH regulatory guidance and compliance.
Excellent communication and interpersonal skills across technical and non-technical stakeholders.
Strong collaborative and mentorship abilities.
Strategic, analytical, and detail-oriented with the ability to manage complex programs.
Compensation & Benefits
Base Salary: $174,500 – $274,230
Short- and long-term incentive plans
Full health benefits (medical, dental, vision)
401(k) with company match
Life insurance, disability coverage, tuition reimbursement
Paid vacation (up to 120 hours/year), sick leave (up to 80 hours/year), holidays
Volunteer time off and well-being initiatives
Equal Opportunity
Takeda is committed to building a diverse workforce and provides equal employment opportunities to all applicants and employees regardless of background or protected status under the law.
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