Associate Director, Clinical Pharmacology

Takeda•Boston, MA

1d•$154,400 - $242,550•Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Clinical Pharmacology in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. 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.

Requirements

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.
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
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

Nice To Haves

Experience in plasma derived/related therapies is preferred

Responsibilities

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.