Sr. Director, Clinical Operations- NAEU

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 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 Kirins Clinical Operations organization. This role is responsible for leading and overseeing Phase IIV interventional clinical trials across multiple therapeutic areas ensuring strategic alignment and operational excellence in support of the companys global objectives.

The Senior Director will provide high-level leadership and direction across all aspects of clinical trial executiondriving 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 Kirins 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 stakeholdersincluding senior leadership investigators and KOLsto align quality objectives and promote accountability.

Requirements:

Education
Bachelors degree in Life Sciences Nursing Pharmacy or a closely discipline is required. Advanced degree such as Masters PharmD PhD or MBA is strongly preferred particularly with a focus in clinical research healthcare or business administration..

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.
Proven success in leading complex global Phase IIV clinical programs in matrixed cross-regional environments; oncology and/or rare disease experience strongly preferred.
Demonstrated expertise in early-phase development with hands-on experience managing trials across diverse regulatory landscapes (e.g. FDA EMA PMDA).
Extensive experience in CRO and vendor oversight including performance management quality control and hybrid operating models and vendor selection to ensure high-quality and timely trial execution.
Strong track record of regulatory compliance and inspection readiness including audit preparation response and CAPA execution.
Proven ability to lead develop and engage cross-functional multi-regional teams effectively managing across time zones and cultures.
Demonstrated capability in driving operational excellence including process optimization metrics-based performance management and adoption of innovative technologies (e.g. AI digital platforms).

Technical Skills
Deep knowledge of global regulatory frameworks and clinical development standards including FDA EMA PMDA regulations and ICH-GCP guidelines.
Proven expertise in process optimization risk mitigation and quality management systems to drive operational excellence and compliance.
Proficient in clinical trial documentation and operational systems including Clinical Trial Management Systems (CTMS) electronic Trial Master File (eTMF) and project management tools such as Planisware or similar platforms.
Skilled in budget planning financial oversight and contract negotiations collaborating closely with finance and legal teams to ensure cost-effective clinical program delivery.
Strong command of data analytics and performance metrics leveraging dashboards and KPIs to monitor study progress and inform strategic decisions.
Experience with digital R&D intelligence platforms (e.g. Citeline Trialtrove) and a strong understanding of emerging clinical technologies including AI-driven tools eConsent remote monitoring and decentralized trial solutions.
Excellent written verbal and listening communication skills; articulate and effective communicator and presenter including global audience.
Proficiency in Microsoft Office Suite (Excel Word Outlook etc.).Non-Technical Skills

Leadership
Exceptional leadership and influencing skills within complex global matrix organizations with proven ability to align diverse stakeholders around common goals.
Strategic thinker with deep expertise in driving operational excellence and successful clinical trial execution at scale.
High emotional intelligence and cultural sensitivity adept at fostering collaboration and building consensus across regions functions and cultures.
Skilled in navigating ambiguity and change management with a calm decisive leadership style that drives progress in dynamic environments.
Cultural sensitivity and ability to develop consensus within a multinational organization.

Working Conditions:

This role operates in a global cross-functional environment and requires adaptive flexibility including participation in early morning or evening virtual meetings to collaborate effectively with international teams and study sites across multiple time zones. The position follows a hybrid work model with an expected on-site presence of two days per week or eight days per month supporting a balance between purposeful in-person collaboration and personal flexibility. The role requires up to 25% domestic and international travel to support global clinical studies and engage with regional teams and key stakeholders.

The anticipated salary for this position will be$260000 to $275000. 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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