Director, Clinical Pharmacology

Takeda • Boston, MA

5d • 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 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 strong strategic thinking, excellent verbal and written communication skills, and in-depth Clinical Pharmacology and PK/PD knowledge.

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.
• 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 identiy 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, analytical, and organizational skills
• Demonstrated ability to successfully manage external consultants/vendors
• 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 regulations and familiarity with GLP and GMP requirements
• Sound knowledge of the drug development process, and a detailed understanding of non-clinical and clinical DMPK processes

Nice To Haves

• Experience in plasma derived/related therapies highly desired

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.
• 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.
• 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 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree