Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Position Summary:

The Director, CRO Excellence & Delivery is responsible for ensuring high-quality, predictable delivery of outsourced Phase I–IV clinical trials through effective CRO and vendor oversight. This role serves as a senior operational leader accountable for CRO performance, governance, financial discipline, and issue resolution across global clinical programs.

The Director partners closely with Clinical Operations, Clinical Development, Project Leadership, and with  internal/external functional teams to ensure that outsourcing strategies are executed effectively, risks are identified early, and vendors deliver against contractual, quality, and timeline expectations.

This role requires proven CRO experience and delivery of clinical programs, strong understanding of clinical trial processes, ICH-GCP, SOPs and regulatory requirements.

Responsibilities:

CRO & Vendor Delivery Oversight

• Provide senior operational oversight of CROs and functional service providers supporting outsourced Phase I–IV clinical trials
• Ensure CRO and vendor delivery aligns with approved program timelines, budgets, scope, and quality expectations
• Monitor performance proactively and identify emerging risks or inefficiencies early

• Lead CRO initiatives to evaluate, streamline, and enhance clinical trial operations, reducing delays and boosting productivity

• Drive timely issue resolution and escalation through defined governance pathways when required
• Serves as an escalation point of accountability for CRO-related operational performance

Governance Management

• Develop operational relationships with CROs in alignment with established governance frameworks and partnership operational manuals
• Contribute to CRO performance evaluations, lessons learned, and continuous improvement planning
• Participate in and lead discussions within vendor governance forums, including Operational Committee meetings, and provide input into Steering Committee-level discussions
• Foster strong, collaborative relationships with internal teams and external partners

Financial & Operational Discipline

• Support alignment between CRO execution and approved budgets, including monitoring of spend versus work performed including third party CRO vendors
• Partner with Project Leadership and other functional areas to support forecasting accuracy and financial transparency
• Identify operational drivers of CRO budget risk and support mitigation strategies
• Manage CRO cost control measures to ensure alignment with approved budget and FTE management
• Provide expertise to CRO related budget and contract negotiations

Process Improvement & CRO Excellence

• Identify opportunities to improve outsourcing models, CRO oversight practices, and operational efficiency
• Contribute to the development, implementation, and adoption of operational best practices related to outsourcing and governance
• Support process mapping, documentation, and rollout of continuous improvement initiatives
• Drive consistency in how CROs are managed across studies and programs

Quality, Compliance & Inspection Readiness

• Ensure vendor-conducted activities comply with ICH-GCP, regulatory requirements, and internal SOPs, as applicable
• Monitor alignment between CRO processes and internal quality systems
• Support inspection readiness for outsourced trial components
• Participate in audits and regulatory inspections as needed, ensuring appropriate preparation and follow-up

Leadership & Capability Building

• Serve as a mentor and resource to Global Operational Leaders, Clinical Trial Managers, and others involved in CRO oversight
• Provide input into team development efforts, including training, knowledge sharing, and capability building related to outsourcing and governance
• Lead through influence by modeling strong CRO partnership behaviors, accountability, and decision-making

Education/Requirements:

• Bachelor’s degree in life sciences, healthcare, or related field (advanced degree preferred)
• 10+ years of experience in clinical trial operations, including significant experience in CRO and vendor oversight
• Demonstrated experience managing CROs and functional vendors across global Phase I–IV clinical studies
• Strong understanding of clinical trial processes, ICH-GCP, and global regulatory standards
• Proven ability to identify operational inefficiencies and contribute to practical, scalable solutions
• Experience operating effectively in matrixed, cross-functional environments
• Strong organizational, interpersonal, and communication skills
• Ability to influence outcomes, manage escalation, and drive alignment across internal and external stakeholders

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com.

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.