Associate Director, Clinical Pharmacology

Position Objectives

PDT BU R&D advances plasma-derived therapies for patients with rare and complex diseases. Takeda sees substantial potential to better address the needs of patients and healthcare providers across immunologic, hematologic, and other complex conditions.

Works effectively in a highly matrixed environment, collaborating closely with relevant Takeda and PDT BU functions to advance the PDT R&D portfolio. Contributes to clinical pharmacology and pharmacometrics strategies that support PDT projects from entry into clinical development through lifecycle management. Serves as Clinical Pharmacology Lead and/or Pharmacometrics Lead for PDT projects and supports regulatory submissions and interactions. Requires strategic thinking, strong written and verbal communication, and deep expertise in clinical pharmacology and pharmacometrics.

Position Accountabilities

• Represent Clinical Pharmacology on Clinical Study Team, product development team and other multifunctional teams as needed.
• Plan and oversee clinical pharmacology aspects at study/program level (e.g., dose justification, PK/biomarker/immunogenicity measurement strategies, protocol authoring, clinical pharmacology analysis plan authoring, modeling and simulation analysis plan authoring, clinical phase oversight, reporting).
• Design and execute clinical pharmacology plans and modeling and simulation plans to support the development, registration and commercialization of Takeda’s plasma derived products.
• Identify, design, conduct and/or oversee pharmacometrics projects and/or other type of modeling projects to support the program development and regulatory submissions.
• Responsible for ensuring use of appropriate analytical methods to integrate knowledge of PK, PD, patient characteristics and disease state to optimize dose regimens and study design.
• Contribute to regulatory documents (e.g., Briefing books, Investigator’s Brochures, IND, BLA, Labeling, Regulatory query responses), 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.
• Manage outsourcing activities (e.g., contract requisition, SOW and approval invoices) with operational and scientific oversight.

Education, Behavioral Competencies and Skills

A Ph.D., Pharm D, or equivalent training in pharmacy, pharmacometrics, pharmaceutical sciences, medical, engineering, applied mathematics or related discipline, with 5+ year clinical pharmacology experience in the pharmaceutical industry. Hands-on experience on pharmacometrics or other types of modeling and simulation is necessary.

Skills

• Ability to work independently, take initiative and complete tasks to deadlines
• Ability to proactively identify issues and solve problems.
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Proven ability to work effectively in a matrixed environment
• Proven ability to effectively present information to cross-functional teams and management
• Excellent interpersonal, verbal and written communication, analytical, and organizational skills
• Proven judgment and decision-making skills with the ability to understand how decisions fit into the broader R&D portfolio
• Diplomacy and positive influencing abilities
• Demonstrated ability to set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work.
• Demonstrated ability to successfully manage clinical pharmacology and pharmacokinetic aspects of regulatory agency interactions and label negotiations
• Demonstrated ability to stay abreast of literature, regulatory guidance documents and SOPs
• Demonstrated ability to successfully manage external consultants/vendors

Knowledge

• Deep clinical pharmacology knowledge relevant to large molecule drug development
• Strong quantitative skills and expertise (e.g., hands-on experience with pharmacometrics, PK/PD, mechanistic modeling using Monolix, R, etc.)
• Knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration
• Sound knowledge of clinical pharmacology requirements in regulatory documents (e.g., Briefing books, Investigator’s Brochures, IND, BLA, Labeling)
• Sound knowledge of the drug development process, and an intimate understanding of clinical operation and bioassay processes
• Sound working knowledge of the cross-functional interfaces that are important for efficient drug development
• Experience in plasma derived/related therapies is preferred