Senior Manager, Clinical Outsourcing

Role Summary

The Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing for Jazz Pharmaceuticals’ clinical development programs across clinical study phases pre- and post-authorization. Under the direction of leadership in Clinical Outsourcing, s/he is responsible for vendor evaluation and selection, contract negotiation and maintenance, and vendor relationship management processes in support of Jazz’s clinical studies.

Responsibilities

• Collaborates with cross-functional (Legal, Finance, FP&A, Clinical Operations, etc.) departments relating to developing and managing vendor contracts and budgets and managing vendor performance.
• Collaborates with vendors to proactively manage risk, resolve issues, address questions, and optimize ways of working as outsourcing partners
• Leads the vendor evaluation and selection process in accordance with clinical outsourcing and clinical sub-category strategies, partnering with internal Jazz stakeholders and cross-functional business partners
• Generates RFPs, RFIs and contract templates in support of the clinical outsourcing process and in compliance with standard operating procedures and policies
• Negotiates clinical vendor contracts and budgets, including MSAs and statement of work (SOWs) for CROs and other clinical category vendors
• Acts as an issue escalation point for study teams managing and escalating vendor performance issues, as required and in accordance with vendor governance charters and established issue escalation pathways
• Represents Clinical Outsourcing to cross-functional teams/clinical trial working groups, coaching R&D on current processes and policies as it relates to Clinical Outsourcing and the clinical contracts process, as required
• Submits and manages purchase requisitions and contracts through the approval process in Jazz’s S2P system
• May lead or participate in departmental initiatives/projects in support of Jazz R&D and/or Global Procurement
• May develop and lead clinical sub-category strategy(s) and key vendor relationship(s)
• May lead or support vendor governance activities, as required
• May supervise and contribute to the training and professional development of staff

Qualifications

• Required: Minimum 5 years of clinical outsourcing experience
• Preferred: Experience in Neurology and/or Oncology
• Required: Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
• Required: Must have a comprehensive understanding of the drug development process
• Required: Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
• Required: Experience collaborating cross-functionally to develop RFPs, RFIs, and study budget/contract templates
• Required: Proven track record negotiating complex clinical services contracts and budgets with both U.S. and international vendors
• Required: In-depth knowledge of compliance and legal issues related to the conduct of clinical trials (phases 1–3; post-authorization phase 4 preferred)
• Required: Experience managing CROs, central laboratories, and other clinical study vendor relationships
• Required: Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
• Required: Demonstrated strength in time and project management with the ability to prioritize and handle multiple competing tasks simultaneously and under pressure
• Required: Alignment with Jazz values (Passion, Innovation, Collaboration, Integrity and Pursuit of Excellence)
• Required: Some limited travel may be required

Education

• Bachelor’s degree required; Master’s degree (MS, MBA) preferred

Additional Requirements

• Remote