Director, Clinical Pharmacology

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Job Description

Director, Clinical Pharmacology

Cambridge, MA

Hybrid

OBJECTIVES/PURPOSE

The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases.

• This individual will work in a highly matrixed team setting and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to support project goals.
• This individual will contribute to the clinical pharmacology and pharmacometrics strategy to support PDT project progression from entry to clinical development to life cycle management
• This individual will act as the global clinical pharmacology lead on PDT projects and contribute to regulatory submissions and interactions.
• This role requires a strong strategic thinking, excellent verbal and written communication skills, and in-depth Clinical Pharmacology and PK/PD knowledge.

ACCOUNTABILITIES

• Design clinical pharmacology programs to support the development, registration, and commercialization of Takeda’s plasma derived products.
• Represent Clinical Pharmacology on different product development teams. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response, and pediatric development.
• Leads study design, execution, and reporting of clinical pharmacology studies
• Identify, design, conduct and/or oversee pharmacometrics projects to support the program progression and regulatory submissions. The relevant pharmacometrics projects may include and are not limited to non-compartmental PK, PK/PD analyses, population PK and PK/PD, and other modeling and simulation activities as appropriate for the project.
• Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory strategies, 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.
• Write/Review Clinical Pharmacology Plans and Reports, as well as relevant sections of CSRs.
• Manage outsourcing activities and approved budget accordingly. Manage contract requisition, SOW and approval of invoices.
• May participate in identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• A Ph.D., Pharm D, MD or equivalent degree with at least 10 years of clinical pharmacology experience within the pharmaceutical industry.
• Educational background in clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, or a related field.

Skills

• Demonstrated ability to successfully manage the clinical pharmacology/pharmacokinetic components of multiple drug products across all phases of development
• Demonstrated ability to successfully manage clinical pharmacology and pharmacokinetic aspects of regulatory agency interactions and label negotiations
• Ability to work independently, take initiative and complete tasks to deadlines
• Ability to proactively identify issues and solve problems.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
• Proven ability to work effectively in a matrixed environment
• Ability to effectively present information to management at all levels of the organization
• Demonstrated ability to set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. 
• Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of PDT R&D strategies.
• Diplomacy and positive influencing abilities
• Excellent interpersonal, verbal and written communication, analytical, and organizational skills
• Demonstrated ability to successfully manage external consultants/vendors

Knowledge

• Deep understanding and direct experience with pharmacometrics, PK/PD and statistical analysis using NonMEM, Phoenix NLME and other relevant data analysis tools.
• Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.
• Knowledge of the latest developments in clinical pharmacology, pharmacometrics and regulatory guidance documents.
• Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
• Sound knowledge of GCP regulations and familiarity with GLP and GMP requirements
• Sound knowledge of the drug development process, and a detailed understanding of non-clinical and clinical DMPK processes
• Sound working knowledge of the cross-functional interfaces that are important for efficient drug development
• Experience in plasma derived/related therapies highly desired

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

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EEO Statement

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