Director - Scientific Data Analysis - Boston, MA, United States - Takeda Pharmaceutical Company Limited

Description

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Director, Clinical Pharmacology

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.

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. 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.
Pharm D 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.
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.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Ability to effectively present information to management at all levels of the organization
Demonstrated ability to successfully manage external consultants/vendors.

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.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
#The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. S.

based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

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.

Full time
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