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

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

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.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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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