Director, Clinical Pharmacology

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, Clinical Pharmacology will serve as the Clinical
Pharmacology representative and subject matter expert (SME) on 
internal development project teams, responsible for the clinical
pharmacology profiling of small molecule and biologic drugs in 
therapeutic areas that include oncology, nephrology, and/or 
immunology. The Director, Clinical Pharmacology will be 
accountable for the design and implementation of the clinical 
pharmacology plans using traditional and model informed drug 
development (MIDD) approaches that will be used to help 
facilitate and accelerate drug development. The Director, Clinical 
Pharmacology will play a pivotal role in the design, planning, execution, and interpretation of clinical pharmacology studies 
conducted in early, full and life cycle management phases of 
clinical development. The Director, Clinical Pharmacology will 
provide input to all applicable clinical development plans, 
protocols, and clinical study reports. The Director, Clinical 
Pharmacology will be responsible for the preparation of the 
clinical pharmacology components of regulatory submissions and 
will represent Clinical Pharmacology at meetings with health 
authorities. The Director, Clinical Pharmacology will also help 
develop and implement processes to improve conduct and
management of activities in Clinical Pharmacology group.

Essential Functions:

•    Serve as the clinical pharmacology SME on cross-functional clinical and study teams for development projects
•    Responsible for development, planning and execution of clinical pharmacology strategies to support drug development across all phases including life cycle management and global regulatory registrations
•    Responsible for designing, coordinating, analyzing, and interpreting clinical pharmacokinetic/pharmacodynamic studies.
•    Responsible for the preparation of biopharmaceutics and clinical pharmacology summaries of regulatory submissions.
•    Maintain a thorough understanding of regulatory expectations and represent the function at the meetings with regulatory authorities
•    Establish processes and capabilities for effective implementation of clinical pharmacology and pharmacometrics strategies for various small molecule/biologics programs at clinical stages
•    Collaborate effectively within Global Clinical Pharmacology and cross-functionally within Global Development on project teams to help make data informed development decisions.
•    Mentor Clinical Pharmacology Leads and other cross-functional partners in a matrix environment to increase organizational knowledge in MIDD and clinical pharmacology concepts
•    Based on skill and experience, manage Clinical Pharmacology Leads, ensuring their professional growth and successful delivery of clinical pharmacology objectives to development teams 
•    Present and author scientific publications, sharing insights and research outcomes with the broader scientific community.

Requirements:

Education
PhD preferred, or MS or PharmD with specialty training in Clinical Pharmacology/Pharmacometrics or research fellowship

Experience
•    Minimum 7 years of pharmaceutical industry experience gained in Clinical Pharmacology 
•    Knowledge and experience in the application of MIDD, including the development of clinical pharmacology plans that can influence drug development.
•    Knowledge of the current practices in the areas of clinical pharmacology, pharmacokinetics, and/or drug metabolism.
•    Experience of working on the development of small molecules and/or large molecule biologics.
•    Experience in working across the drug development spectrum; experience working on medicines during post-marketing life cycle management is a plus.
•    Experience in development and writing of regulatory communications, including summary documents, and query responses
•    Experience of working collaboratively with cross-functional partners on project teams, enabling data driven drug development decisions 
•    Experience mentoring and managing directly or in a matrix environment is a plus
•    Experience working at a Japanese based pharmaceutical company a plus 

Technical Skills
Profi