Director, Clinical Pharmacology

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a 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: 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. POSITION ACCOUNTABILITIES: 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. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response, and pediatric development. 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 relevent 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 relevent 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. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: 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. Skills 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 Ability to work independently, take initiative and complete tasks to deadlines Ability to proactively identify issues and solve problems. Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines Proven ability to work effectively in a matrixed environment Ability to effectively present information to management at all levels of the organization Demonstrated ability to set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work.  Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of PDT R&D strategies. Diplomacy and positive influencing abilities Excellent interpersonal, verbal and written communication communication, analytical, and organizational skills Demonstrated ability to successfully manage external consultants/vendors Knowledge 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 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 Sound knowledge of GCP re