Role Overview for VP, Clinical Outsourcing Management with a Vaccine Producer – San Jose, CA
JRG Partners is proud to partner with a pioneering, research-driven vaccine producer in their search for a Vice President of Clinical Outsourcing Management. Located in the heart of innovation in San Jose, CA, our client is at the forefront of developing next-generation vaccines to combat global health threats. This is a rare opportunity to join a dynamic executive team and build a world-class clinical outsourcing function that will directly influence the speed, quality, and success of critical clinical development programs.
As the VP of Clinical Outsourcing Management, you will be the strategic architect and operational leader responsible for the entire lifecycle of vendor and CRO partnerships. Reporting directly to the Chief Development Officer, you will develop and execute a global sourcing strategy that aligns with the company’s ambitious clinical pipeline. You will provide inspirational leadership to a growing team, fostering a culture of excellence, accountability, and strategic partnership. This role requires a visionary leader with deep industry expertise, exceptional business acumen, and a proven track record of managing complex, multi-million dollar clinical outsourcing budgets. Your work will be pivotal in enabling the organization to deliver life-saving vaccines to populations in need around the world.
Key Responsibilities of VP, Clinical Outsourcing Management with a Vaccine Producer – San Jose, CA
The Vice President of Clinical Outsourcing Management will have a broad and impactful remit, overseeing all aspects of clinical vendor strategy and management. Key responsibilities include:
Strategic Leadership and Planning
- Develop, implement, and continuously refine the global clinical outsourcing and vendor management strategy in alignment with corporate objectives and clinical development plans.
- Serve as the senior subject matter expert on outsourcing models, industry trends, and vendor capabilities, providing strategic guidance to executive leadership and clinical teams.
- Lead long-range capacity and demand planning to ensure the necessary external resources are secured to support a rapidly growing and evolving clinical pipeline.
- Establish a robust governance framework for vendor selection, oversight, and performance management to ensure quality, compliance, and value.
Vendor Selection and Management
- Lead the end-to-end vendor selection process, from Request for Information (RFI) and Request for Proposal (RFP) development to vendor qualification, bid defense meetings, and final selection.
- Cultivate and manage strategic relationships with key Contract Research Organizations (CROs) and other clinical service providers (e.g., central labs, imaging vendors, eCOA providers).
- Establish and lead cross-functional vendor governance committees, conducting regular business and operational review meetings to monitor performance, address issues, and drive continuous improvement.
- Develop and implement comprehensive vendor oversight plans, ensuring adherence to contractual obligations, timelines, budgets, and quality standards.
- Act as the primary point of escalation for resolving complex vendor-related issues, working collaboratively with internal and external stakeholders to find effective solutions.
Financial and Contractual Oversight
- Oversee the departmental budget, including forecasting, tracking, and reporting on all clinical outsourcing expenditures.
- Lead the negotiation of complex Master Service Agreements (MSAs), Statements of Work (SOWs), change orders, and other contractual documents in partnership with Legal and Finance departments.
- Drive cost-efficiency and value creation by implementing effective negotiation strategies, exploring innovative pricing models, and ensuring financial transparency from vendors.
- Ensure accurate and timely processing of vendor invoices and reconciliation against approved budgets and work orders.
Process Development and Operational Excellence
- Establish and optimize departmental Standard Operating Procedures (SOPs), work instructions, and best practices for all outsourcing activities.
- Develop, track, and report on key performance indicators (KPIs) and metrics to measure vendor performance and the effectiveness of the outsourcing function.
- Champion a culture of continuous improvement, identifying and implementing innovative solutions, technologies, and processes to enhance efficiency and quality.
- Ensure all outsourced activities are conducted in strict compliance with international regulations, industry standards, and corporate policies, particularly Good Clinical Practice (GCP) guidelines.
Team Leadership and Development
- Build, lead, and mentor a high-performing team of clinical outsourcing and vendor management professionals.
- Provide clear direction, set performance objectives, and foster the professional growth and development of team members.
- Promote a collaborative, inclusive, and results-oriented team culture that is tightly integrated with other functions such as Clinical Operations, Project Management, Finance, and Quality Assurance.
Requirements for the VP, Clinical Outsourcing Management with a Vaccine Producer – San Jose, CA
We are seeking a seasoned and strategic leader with extensive experience in the biopharmaceutical industry. The ideal candidate will possess a unique blend of scientific understanding, business savvy, and leadership presence.
Required Qualifications
- Bachelor’s degree in a life science, business, or related field is required.
- A minimum of 15 years of progressive experience in the pharmaceutical, biotechnology, or CRO industry.
- At least 10 years of direct experience in clinical outsourcing, procurement, vendor management, or a closely related function.
- A minimum of 7 years of experience in a senior leadership role with significant people management and team-building responsibilities.
- Direct experience managing outsourcing for vaccine or biologics clinical trials is essential.
- Proven track record of successfully negotiating multi-million dollar, complex clinical service agreements.
- Demonstrated experience managing global clinical trials and working with international vendors.
- In-depth knowledge of the end-to-end clinical development process, drug development regulations, and ICH/GCP guidelines.
Preferred Qualifications
- An advanced degree (e.g., MS, MBA, PhD, PharmD) is highly preferred.
- Experience building a clinical outsourcing function from the ground up or leading a significant transformation of an existing function.
- Experience with a variety of therapeutic areas, with a strong preference for infectious diseases.
- Established network of contacts within the CRO and clinical vendor landscape.
Essential Skills & Competencies
Strategic Mindset
Ability to see the bigger picture, anticipate future trends, and develop robust, long-term strategies.
Leadership & Influence
Exceptional ability to lead teams, influence stakeholders at all levels, and drive organizational change.
Negotiation & Financial Acumen
Masterful negotiation skills with a deep understanding of financial principles, budgeting, and cost control.
Communication
Outstanding verbal, written, and presentation skills, with the ability to convey complex information clearly and concisely to diverse audiences.
Problem-Solving
Strong analytical and critical thinking skills with a proactive, solutions-oriented approach to challenges.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, including:
Competitive Compensation
A lucrative base salary, a significant annual performance-based bonus, and a substantial equity package (stock options and/or RSUs).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your dependents, along with wellness programs and a fitness reimbursement plan.
Retirement Savings
A robust 401(k) plan with a generous company matching contribution.
Work-Life Balance
A generous paid time off (PTO) policy, company-paid holidays, and parental leave programs.
Professional Development
A dedicated budget for attending conferences, pursuing certifications, and other professional growth opportunities.
Relocation Support
A comprehensive relocation package is available for exceptional candidates.
On-Site Amenities
A modern campus environment with on-site amenities to support a productive and collaborative work experience.
How to Apply
If you are a visionary clinical outsourcing leader passionate about making a tangible impact on global health, we want to hear from you. This is a unique opportunity to shape the future of a leading vaccine innovator. To be considered for this pivotal role, please submit your resume and a cover letter detailing your relevant experience. JRG Partners specializes in connecting top-tier talent with leading companies in the life sciences.
