Director, Clinical Pharmacology
$177,000–$278,080 year
On-siteCambridge, Massachusetts, United States
Job Summary
Design clinical pharmacology programs to support the development, registration, and commercialization of Takeda's plasma-derived products. Lead study design, execution, and reporting for clinical pharmacology studies, including dose finding, optimization, and pediatric development. Identify, design, and oversee pharmacometrics projects such as non-compartmental PK, population PK, and modeling simulations to support regulatory submissions. Contribute to regulatory documents, including Investigator Brochures and labeling, and provide resolution for regulatory agency queries. Manage outsourcing activities, budgets, and contract requisitions while participating in business development due diligence. Act as the global clinical pharmacology lead for PDT projects, ensuring close collaboration across R&D functions.
Required Qualifications
- A Ph.D., Pharm D, MD or equivalent degree
- 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 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
- 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
- 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
- Sound working knowledge of the cross-functional interfaces that are important for efficient drug development
- Experience in plasma derived/related therapies
- Hybrid work arrangement
Desired Qualifications
- Experience in plasma derived/related therapies highly desired
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.