Kyowa Kirin, Inc.- U.S.
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 • 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
Working Conditions Requires up to 10% domestic and international travel
Compensation The anticipated salary for this position will be
$200,000 to $230,000 . The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job‑based knowledge, location, and other business and organizational needs).
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)
Well‑Being and Work/Life Programs
Life & Disability Insurance
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards
Equal Employment Opportunity 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 citizenship status or any other category protected by law.
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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 • 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
Working Conditions Requires up to 10% domestic and international travel
Compensation The anticipated salary for this position will be
$200,000 to $230,000 . The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job‑based knowledge, location, and other business and organizational needs).
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)
Well‑Being and Work/Life Programs
Life & Disability Insurance
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards
Equal Employment Opportunity 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 citizenship status or any other category protected by law.
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