Senior Manager, Strategic Outsourcing
Category: Research & Development | Country: United States | State: California | City: Palo Alto| Type: Regular, Full Time | Job ID: 4668
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and haematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Manager, Strategic Outsourcing, Clinical Operations will manage the outsourcing and contracts management process for Jazz Pharmaceuticals’ clinical development programs. S/he must have an expert and comprehensive understanding of all functions and regulations required to conduct international clinical studies.
Under the direction of the Senior Director, Strategic Outsourcing, Clinical Operations, s/he is responsible for the vendor selection, contract negotiation and maintenance, and financial management processes in support of Jazz’s clinical studies.
Senior Manager, Strategic Outsourcing, Clinical Operations will:
- Partners with internal Jazz stakeholders to develop, deliver and maintain operational sourcing strategies and relationships.
- Works with vendors for resolution of issues and questions,
- Collaborates with cross-functional (Legal, Finance, FP&A, Clinical Operations, Data Management and Biostats) departments on activities relating to vendors and business partners
- Managing departmental initiatives/projects, in support of Jazz R&D.
- Assist Senior Director in the management of the outsourcing, vendor selection and clinical contracts process
- Generate RFPs, RFIs and contract templates
- Creates and provides budget forecasts for clinical projects for the business as requested
- Manages the negotiation of clinical development contracts, including MSAs, CDAs, clinical sites, CROs, central laboratories, consultants and specialty vendors
- Manages the selection and negotiation process with vendors and sites in conjunction with functional teams
- Represents Strategic Outsourcing to cross-functional teams, providing training on contract request process as required
- Takes a leadership role in coaching R&D on current processes and policies as it relates to Compliance and Outsourcing
- Manage tracking tools (spreadsheets, databases, etc.),
- Manage/supervise employee(s).
- Bachelor’s degree with seven years of contract experience in the pharmaceutical or biotechnology industry
- Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
- Extensive experience generating RFPs, RFIs, and study budget/contract templates
- Proven track record negotiating contracts and budgets with international vendors and clinical sites
- In-depth knowledge of compliance and legal issues related to the conduct of clinical trials
- Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
- Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
- Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
- Ability to prioritize and handle multiple tasks simultaneously
- Maintain up to date information on changing healthcare regulations affecting clinical trial payments
- Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.
- Some limited travel may be required
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.