Associate Director, Clinical Pharmacology

Takeda Pharmaceutical Co.; Boston (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Clinical Pharmacology in the Cambridge, MA area. You will lead clinical pharmacology strategy, PK/PD modeling, and regulatory interactions to support PDT plasma-derived therapies.

The role requires a PhD/PharmD with 5+ years in pharma and hands-on modeling experience. Hybrid work is offered with collaboration across matrixed teams to advance regulatory filings and product development.

Qualifications

• PhD, PharmD or equivalent with 5+ years in clinical pharmacology within pharma.
• Hands-on pharmacometrics or modeling/simulation experience is required.
• Experience contributing to regulatory submissions and inquiries.

Responsibilities

• Represent Clinical Pharmacology on study teams and cross-functional groups.
• Plan and oversee clinical pharmacology aspects at the study/program level.
• Design and execute pharmacology and modeling plans for development/registration.
• Identify and manage pharmacometrics projects to support submissions.
• Contribute to regulatory documents and respond to queries from agencies.
• Oversee outsourcing activities with scientific and operational oversight.

Skills

Clinical pharmacology

Pharmacometrics

Modeling & simulation

Regulatory submissions

Cross-functional collaboration

Education

PhD/PharmD

Tools

Monolix

R

Job description

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Clinical Pharmacology 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.

POSITION OBJECTIVES:

PDT BU R&D advances plasma-derived therapies for patients with rare and complex diseases. Takeda sees substantial potential to better address the needs of patients and healthcare providers across immunologic, hematologic, and other complex conditions.

• Works effectively in a highly matrixed environment, collaborating closely with relevant Takeda and PDT BU functions to advance the PDT R&D portfolio.
• Contributes to clinical pharmacology and pharmacometrics strategies that support PDT projects from entry into clinical development through lifecycle management.
• Serves as Clinical Pharmacology Lead and/or Pharmacometrics Lead for PDT projects and supports regulatory submissions and interactions.
• Requires strategic thinking, strong written and verbal communication, and deep expertise in clinical pharmacology and pharmacometrics.

POSITION ACCOUNTABILITIES:

• Represent Clinical Pharmacology on Clinical Study Team, product development team and other multifunctional teams as needed.
• Plan and oversee clinical pharmacology aspects at study/program level (e.g., dose justification, PK/biomarker/immunogenicity measurement strategies, protocol authoring, clinical pharmacology analysis plan authoring, modeling and simulation analysis plan authoring, clinical phase oversight, reporting).
• Design and execute clinical pharmacology plans and modeling and simulation plans to support the development, registration and commercialization of Takeda’s plasma derived products.
• Identify, design, conduct and/or oversee pharmacometrics projects and/or other type of modeling projects to support the program development and regulatory submissions. Responsible for ensuring use of appropriate analytical methods to integrate knowledge of PK, PD, patient characteristics and disease state to optimize dose regimens and study design.
• Contribute to regulatory documents (e.g., Briefing books, Investigator’s Brochures, IND, BLA, Labeling, Regulatory query responses), interactions and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries.
• Manage outsourcing activities (e.g., contract requisition, SOW and approval invoices) with operational and scientific oversight.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• A Ph.D., Pharm D, or equivalent training in pharmacy, pharmacometrics, pharmaceutical sciences, medical, engineering, applied mathematics or related discipline, with 5+ year clinical pharmacology experience in the pharmaceutical industry.
• Hands-on experience on pharmacometrics or other types of modeling and simulation is necessary.

Skills

• Ability to work independently, take initiative and complete tasks to deadlines
• Ability to proactively identify issues and solve problems.
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Proven ability to work effectively in a matrixed environment
• Proven ability to effectively present information to cross-functional teams and management
• Excellent interpersonal, verbal and written communication, analytical, and organizational skills
• Proven judgment and decision-making skills with the ability to understand how decisions fit into the broader R&D portfolio
• Diplomacy and positive influencing abilities
• Demonstrated ability to set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work.
• Demonstrated ability to successfully manage clinical pharmacology and pharmacokinetic aspects of regulatory agency interactions and label negotiations
• Demonstrated ability to stay abreast of literature, regulatory guidance documents and SOPs
• Demonstrated ability to successfully manage external consultants/vendors

Knowledge

• Deep clinical pharmacology knowledge relevant to large molecule drug development
• Strong quantitative skills and expertise (e.g., hands-on experience with pharmacometrics, PK/PD, mechanistic modeling using Monolix, R, etc.)
• Knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration
• Sound knowledge of clinical pharmacology requirements in regulatory documents (e.g., Briefing books, Investigator’s Brochures, IND, BLA, Labeling)
• Sound knowledge of the drug development process, and an intimate understanding of clinical operation and bioassay processes
• Sound working knowledge of the cross-functional interfaces that are important for efficient drug development
• Experience in plasma derived/related therapies is preferred

This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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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:

$154,400.00 - $242,550.00

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.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

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

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.