Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Position Objectives

Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.

POSITION ACCOUNTABILITIES

• Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
• Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum.
• Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
• Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
• Maintains a high standard for good clinical practice, compliance, and ethics.
• Mentors junior staff to promote scientific excellence and individual achievement.
• Participates as a member of Business Development due diligence, when requested.
• Contributes to infrastructure initiatives and/or cross-functional best practice initiatives.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS

• Education: Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PDMS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD
• Technical Skills: Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies. Formulates and executes clinical pharmacology plans including integration of MIDD principles. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others). Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy.

Compensation and Benefits Summary

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.