Senior Manager, Clinical Outsourcing

Jazz Pharmaceuticals•Philadelphia, PA

8d•Remote

About The Position

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Job Description 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 the vendor evaluation and selection, contract negotiation and maintenance, and vendor relationship management processes in support of Jazz’ clinical studies.

Requirements

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

Nice To Haves

Experience in Neurology and/or Oncology preferred
Master’s degree (MS, MBA), preferred

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