Director, Clinical Pharmacology

About the role

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.

Responsibilities

• 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.
• Provide input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response, and pediatric development.
• Lead 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.
• Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory strategies, interactions and regulatory filings.
• 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.

Requirements

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.

Qualifications

• 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.
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Proven ability to work effectively in a matrixed environment.
• Excellent interpersonal, verbal and written communication communication, analytical, and organizational skills.
• Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products.
• Solid knowledge of GCP regulations and familiarity with GLP and GMP requirements.
• Knowledge of the latest developments in clinical pharmacology, pharmacometrics and regulatory guidance documents.
• Deep understanding and direct hands-on 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 plasma derived/related therapies highly desired.

Skills

• Strategic thinking.
• Excellent verbal and written communication skills.
• In-depth Clinical Pharmacology and PK/PD knowledge.

Benefits

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: USA - MA - Cambridge - Kendall Square - 500 U.S. Base Salary Range : $177,000.00 - $278,800.00 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. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.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. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Pay

$177,000.00 - $278,800.00

Schedule

Hybrid