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

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. 

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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.

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Job Exempt