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.  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 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. This role is accountable for seamless in-house operations, rigorous vendor oversight, and the continuous improvement of clinical processes. Success in this position requires a strong focus on innovation, collaboration within a complex global matrix environment, and a commitment to delivering high-quality clinical programs on time and within budget.

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.
•    Drive cross-functional collaboration with global functions including Development, Quality Assurance, Regulatory, Finance, Clinical Supplies, Legal, and external partners, operating effectively within a matrixed structure.
•    Mentor, coach, and develop regional clinical leaders and staff, cultivating a high-performing, inclusive, and culturally aware organization.
•    Promote transparent communication and strong collaboration across regions, time zones, and cultural boundaries to ensure operational alignment and team cohesion.

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 (ICH-GCP, FDA, EMA, PMDA).
•    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.
•    Collaborate with CROs and functional leads on site feasibility and capability assessments, driving optimal site selection, accelerated activation timelines, and strong patient recruitment and retention strategies.
•    Champion and implement scalable, technology-enabled trial capabilities, integrating AI, digital health tools, and patient-centric innovations to enhance trial efficiency and experience.
•    Lead and contribute to global process improvement initiatives, helping to refine governance structures, operational models, and best practices across the Clinical Operations organization.

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.
•    Maintain and enhance SOPs, training programs, and compliance frameworks to support high standards of quality and consistency across clinical operations teams.
•    Lead global operational excellence initiatives focused on process harmonization, risk mitigation, and implementation of performance metrics to drive continuous improvement.
•    Establish and nurture strong partnerships with key internal and external stakeholders—including senior leadership, investigators, and KOLs—to align quality objectives and promote accountability.

Requirements:

Education
Bac