Kyowa Kirin, Inc.- U.S.
Sr. Director, Clinical Operations- NA/EU
Kyowa Kirin, Inc.- U.S., Princeton, New Jersey, us, 08543
Sr. Director, Clinical Operations- NA/EU
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. The Senior Director, Clinical Operations, NA/EU will serve as the regional head for North America and Europe and as a global leader within Kyowa Kirin’s Clinical Operations organization. This role is responsible for leading and overseeing Phase I–IV interventional clinical trials across multiple therapeutic areas, ensuring strategic alignment and operational excellence in support of the company’s global objectives. The Senior Director will provide high-level leadership and direction across all aspects of clinical trial execution—driving performance, quality, and compliance while managing cross-functional teams and clinical vendors. Essential Functions: Leadership • Lead Kyowa Kirin’s Clinical Operations across North America and Europe, serving as the regional head responsible for the successful planning, execution, and delivery of all clinical trial activities in these territories. • Provide strategic and operational leadership to regional clinical operations teams, ensuring alignment with global development priorities and company objectives. • Act as key leader within the Clinical Operations organization, representing NA/EU regions on cross-regional leadership teams, governance bodies, and strategic initiatives. Clinical Trial Execution & Operational Excellence • Lead the planning, execution, and closeout of all NA/EU clinical trials, ensuring delivery on time, within budget, and in full compliance with global regulatory and quality standards. • Oversee integrated trial execution models, managing a hybrid approach that includes both in-house operations and external CRO/vendor partnerships to ensure consistent quality and performance. Quality, Compliance & Continuous Improvement • Ensure all clinical trials are inspection-ready at all times, maintaining full compliance with ICH-GCP, local regulatory requirements, and internal quality standards. • Oversee end-to-end trial quality management, including proactive risk identification, audit preparedness, inspection response coordination, and timely completion of CAPAs. Requirements: Education Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a closely related discipline is required. Advanced degree such as Master’s, PharmD, PhD, or MBA is strongly preferred. Experience • Minimum of 12 years of progressive experience in clinical operations or clinical study management within the pharmaceutical, biotechnology, or CRO industry, including extensive senior leadership responsibility for global teams and full clinical development lifecycles. Technical Skills • Deep knowledge of global regulatory frameworks and clinical development standards, including FDA, EMA, PMDA regulations, and ICH-GCP guidelines. Kyowa Kirin North America offers a comprehensive range of benefits, including 401K with company match, discretionary profit share, annual bonus program, generous PTO and holiday schedule, healthcare benefits, well-being and work/life programs, life & disability insurance, long term incentive program, pet insurance, tuition assistance, and employee referral awards. Kyowa Kirin North America is an equal employment opportunity employer and does not discriminate on the basis of any protected group status under any applicable law.
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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. The Senior Director, Clinical Operations, NA/EU will serve as the regional head for North America and Europe and as a global leader within Kyowa Kirin’s Clinical Operations organization. This role is responsible for leading and overseeing Phase I–IV interventional clinical trials across multiple therapeutic areas, ensuring strategic alignment and operational excellence in support of the company’s global objectives. The Senior Director will provide high-level leadership and direction across all aspects of clinical trial execution—driving performance, quality, and compliance while managing cross-functional teams and clinical vendors. Essential Functions: Leadership • Lead Kyowa Kirin’s Clinical Operations across North America and Europe, serving as the regional head responsible for the successful planning, execution, and delivery of all clinical trial activities in these territories. • Provide strategic and operational leadership to regional clinical operations teams, ensuring alignment with global development priorities and company objectives. • Act as key leader within the Clinical Operations organization, representing NA/EU regions on cross-regional leadership teams, governance bodies, and strategic initiatives. Clinical Trial Execution & Operational Excellence • Lead the planning, execution, and closeout of all NA/EU clinical trials, ensuring delivery on time, within budget, and in full compliance with global regulatory and quality standards. • Oversee integrated trial execution models, managing a hybrid approach that includes both in-house operations and external CRO/vendor partnerships to ensure consistent quality and performance. Quality, Compliance & Continuous Improvement • Ensure all clinical trials are inspection-ready at all times, maintaining full compliance with ICH-GCP, local regulatory requirements, and internal quality standards. • Oversee end-to-end trial quality management, including proactive risk identification, audit preparedness, inspection response coordination, and timely completion of CAPAs. Requirements: Education Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a closely related discipline is required. Advanced degree such as Master’s, PharmD, PhD, or MBA is strongly preferred. Experience • Minimum of 12 years of progressive experience in clinical operations or clinical study management within the pharmaceutical, biotechnology, or CRO industry, including extensive senior leadership responsibility for global teams and full clinical development lifecycles. Technical Skills • Deep knowledge of global regulatory frameworks and clinical development standards, including FDA, EMA, PMDA regulations, and ICH-GCP guidelines. Kyowa Kirin North America offers a comprehensive range of benefits, including 401K with company match, discretionary profit share, annual bonus program, generous PTO and holiday schedule, healthcare benefits, well-being and work/life programs, life & disability insurance, long term incentive program, pet insurance, tuition assistance, and employee referral awards. Kyowa Kirin North America is an equal employment opportunity employer and does not discriminate on the basis of any protected group status under any applicable law.
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