Senior Scientific Director, Clinical Pharmacology

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Job Description

Senior Scientific Director, Clinical Pharmacology

Boston, MA

OBJECTIVES/PURPOSE

The Plasma-Derived Therapies (PDT) Business Unit R&D group is committed to delivering innovative therapeutic solutions using plasma-derived therapies to address rare and complex diseases. At Takeda, we aim to exceed patient and healthcare provider expectations by unlocking the full potential of plasma-derived and plasma-oriented therapies for immunologic, hematologic, and other complex conditions.

This role is pivotal to advancing PDT R&D projects and offers the opportunity to:

• Collaborate within a matrixed team environment, ensuring seamless integration of efforts across PDT BU functions and relevant Takeda R&D functions to achieve business and project goals.
• Lead strategic, scientific, and operational aspects of clinical pharmacology across multiple drug development programs with substantial technical and strategic autonomy, spanning clinical entry through life-cycle management.
• Drive the clinical pharmacology and pharmacometrics strategy to accelerate project progression through clinical stages and ensure robust life-cycle management.
• Act as the global CPED lead for PDT programs, contributing to regulatory submissions and facilitating interactions with regulatory bodies.
• Leverage strong strategic thinking, exceptional communication skills, and extensive expertise in Clinical Pharmacology and PK/PD to deliver impactful results.

ACCOUNTABILITIES

• Design and oversee clinical pharmacology programs to support the development, registration, and commercialization of Takeda’s plasma-derived products. Provide leadership as the Clinical Pharmacology Lead for multiple programs, integrating data across pharmacokinetic, pharmacodynamic, efficacy, and safety measures to optimize dosing strategies.
• Represent CPED on product development teams, providing expertise across all development phases, including dose finding/optimization, exposure-response, and pediatric development strategies. Partner with key functions to execute impactful Model-Informed Drug Development (MIDD) practices.
• Lead clinical pharmacology and/or Phase 1 clinical studies, from study design to execution and reporting, maintaining high standards for accuracy and compliance.
• Manage pharmacometrics projects, including non-compartmental PK analyses, PK/PD modeling, population PK/PD modeling and simulation activities to advance program progression and support regulatory submissions. Oversee outsourcing collaborations, including contracts, Statement of Work (SOW), budget management, and invoice approvals.
• Engage directly with regulatory agencies, representing clinical pharmacology in global regulatory meetings; contribute to regulatory deliverables, such as Investigator Brochures (IBs), product labeling, responses to regulatory queries, and filings while ensuring alignment with regulatory strategy.
• Author and review CPED Development Plans and Reports, as well as related sections of Clinical Study Reports (CSRs).
• Participate in business development evaluations by conducting due diligence and assessing potential opportunities.
• Uphold Takeda’s commitment to Good Clinical Practices (GCP), compliance, and ethical standards.
• Mentor junior team members, fostering scientific excellence and supporting professional growth.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• A Ph.D., Pharm D, MD or an equivalent degree with 15+ years of clinical pharmacology experience in the biopharmaceutical industry.

• Educational background in clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, or related fields.

Skills

• Proven ability to manage clinical pharmacology and pharmacokinetics across multiple drug development stages and regulatory interactions, including label negotiations.
• Ability to work independently, take initiative, and meet deadlines with strong attention to detail.
• Proactive problem-solving and issue identification skills.
• Competency in establishing priorities, scheduling, and composing/proofing materials.
• Effective collaboration and influence within a matrix environment.
• Strong presentation skills and communication across organizational management levels.
• Demonstrated leadership in setting objectives, providing feedback, and appraising team performance.
• Sound decision-making with a strategic understanding of broader PDT R&D goals.
• Diplomacy, positive influence, and interpersonal capabilities.
• Excellent verbal and written communication, analytical, and organizational skills.
• Proven track record of managing external consultants/vendors efficiently.

Knowledge

• Hands-on experience with pharmacometrics, PK/PD analysis, and statistical tools like NONMEM, Phoenix NLME, etc.
• Thorough understanding of Phase I clinical operations, drug development processes, and global regulatory requirements.
• Advanced knowledge of clinical pharmacology, pharmacometrics, and current regulatory guidance.
• Familiarity with biopharmaceutics requirements for clinical/marketing phases.
• In-depth knowledge of GCP regulations, with familiarity in GLP and GMP standards.
• Detailed understanding of cross-functional interfaces critical for drug development efficiency.
• Expertise in plasma-derived/related therapies (highly desirable).

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan

• Tuition reimbursement Company match of charitable contributions

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs

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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:

$208,200.00 - $327,140.00

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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