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Kyowa Kirin, Inc.- U.S. · 11 hours ago

Director, Clinical Pharmacology

Princeton, NJ

Full-time

Hybrid

Director/Executive

$220K/yr - $250K/yr

7+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Director, Clinical Pharmacology will serve as the Clinical Pharmacology representative and subject matter expert on internal development project teams, responsible for the clinical pharmacology profiling of small molecule and biologic drugs, and will play a pivotal role in the design, planning, execution, and interpretation of clinical pharmacology studies.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

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

Qualification

Clinical PharmacologyPharmacometricsMIDDRegulatory SubmissionsPharmacokineticsBiologics DevelopmentMS Office SuiteNONMEMSASMentoring

Required

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

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

Proficient in MS Office Suite

Proficiency in using pharmacokinetic/pharmacometric software tools including NONMEM, r, Phoenix WinNonLin, NMLE, and/or SAS

Hands-on analyses and the application of current practices in the areas of clinical pharmacology, pharmacokinetics, and/or pharmacometrics to guide drug development decisions

Benefits

401K with company match

Discretionary Profit Share

Annual Bonus Program (Sales Bonus for Sales Jobs)

Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days

Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)

HSA & FSA Programs

Well-Being and Work/Life Programs

Life & Disability Insurance

Concierge Services

Long Term Incentive Program (subject to job level and performance)

Pet Insurance

Tuition Assistance

Employee Referral Awards

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (1)

2022 (1)

2021 (1)