Sr. Director, Clinical Pharmacology Lead

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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.

Summary:

The Sr. Director, Clinical Pharmacology Lead will serve as a subject matter expert (SME) within the Global Development Organization (GDO) Clinical Pharmacology (CP) team. This role involves managing clinical pharmacologists and fostering their professional growth while driving the application of quantitative clinical pharmacology throughout the drug development process. The position will be responsible for designing, planning, and interpreting quantitative clinical pharmacology data across early, full, and life cycle management phases of clinical development. The role will contribute to clinical development plans, protocols, and clinical study reports. Additionally, they will oversee the preparation of clinical pharmacology components for regulatory submissions and represent GDO CP in meetings with health authorities. The Sr. Director will help develop and implement processes to improve the execution and management of CP activities within GDO.

Essential Functions:

* Serve as an SME for clinical pharmacology in oncology, providing specialized input and representing CP on cross-functional project teams.
* Design and implement clinical pharmacology plans using both traditional and Model Informed Drug Development (MIDD) approaches to support drug development and accelerate progress across all phases, including early, full, and life cycle management.
* Lead the preparation of biopharmaceutics and clinical pharmacology summaries for regulatory submissions, ensuring alignment with global regulatory expectations.
* Maintain current understanding of regulatory requirements and represent GDO CP in meetings with regulatory authorities.
* As a leader in GDO CP, introduce innovative MIDD concepts to the CP function and drive their integration across global development.
* Manage and mentor direct reports, ensuring their professional growth and successful delivery of clinical pharmacology objectives to development teams
* Collaborate effectively within GDO CP and across other Global Development functions, ensuring alignment and integration of clinical pharmacology strategies.
* Establish and optimize processes and capabilities for the effective implementation of clinical pharmacology and pharmacometrics strategies across small molecule/biologics programs at clinical stages.
* Contribute to scientific publications and presentations, sharing insights and research outcomes with the broader scientific community.

Requirements:

Education
A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology or closely related discipline

Experience
* Minimum 12 years of pharmaceutical industry experience gained in Clinical Pharmacology
* Management of direct reports that includes a demonstrated record of ensuring professional growth of reports and on time meeting of deliverables.
* Demonstrated ownership of clinical pharmacology strategies that broadly support a therapeutic area. Understanding of how quantitative clinical pharmacology contributes to hemato-oncology and/or oncology development is a plus.
* Experience in working across the drug development spectrum; experience working on medicines during post-marketing life cycle management is a plus.
* Experience working at a Japanese based pharmaceutical company a plus.

Technical Skills
* In-depth knowledge of current practices in clinical pharmacology, including the application of MIDD strategies in clinical programs, and the development of clinical pharmacology plans.
* Demonstrated experience with working on large molecule biologics, antibody drug conjugates, and/or cell and gene therapy.
* Advanced proficiency in using clinical pharmacology software tools including, but not limited to NONMEM, r, Phoenix, NMLE, and/or SAS
* Hands-on analyses and application of pharmacometrics, clinical pharmacology, pharmacokinetics, and pharmacodynamics to guide drug development and decision-making.
* Extensive experience in regulatory communications, including preparation of summary documents, responses to regulatory queries, and presenting oral and written content to regulatory authorities.
* Strong written, verbal, and presentation skills, with the ability to effectively communicate complex concepts to diverse audiences.
* Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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