Director, Clinical Outsourcing

The Director of Clinical Outsourcing will be responsible for overseeing the outsourcing of clinical services, including the negotiation and management of contracts and study budgets as well as oversight of the site budget process. This role requires a strong understanding of clinical operations processes and vendor management expertise. The incumbent will work closely with clinical CROs, partners, vendors, and internal stakeholders to ensure the successful execution of clinical trials.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Serve as contact for clinical CROs, vendors, consultants, and other internal or external stakeholders for outsourcing and budget activities.
• Support clinical benchmarking and site budget development, escalation, and payment activities for clinical sites, CROs, and clinical vendors
• Develop and implement a robust, scalable, and efficient site contracting and budgeting process and oversight across all studies.
• Manage the identification and selection process of clinical vendors.
• Oversee the lifecycle of the request for proposal (RFP) process, including bid comparison, review meetings, vendor selection, and MSA and budget contract negotiation.
• Manage work order amendments and change orders to ensure appropriate pricing and timely execution.
• Lead vendor governance meetings with key CRO and vendor partnerships, including the development and implementation thereof.
• Establish metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress.
• Collaborate with relevant departments (e.g., Regulatory Affairs, Quality Assurance, Legal, Finance) for contract review and approval.
• Develop and maintain clear documentation, including RFx templates, change order forms, and confidentiality agreements.
• Ensure outsourced activities comply with regulatory requirements (e.g., GCP, FDA, EMA)
• Partner with quality assurance to oversee audits of external vendors
• Identify and implement processes for outsourcing and vendor management.
• Maintain project-level financial management, including budgeting, forecasting, and invoice reconciliation.
• Provide ad-hoc reporting, analysis, and project support for contract and budget governance
• Support clinical program teams with long-range planning, scenario analysis, and annual budget planning activities
• Build and lead a high-performing clinical outsourcing and vendor management team, including recruiting, training, and mentoring team members.
• Other duties as required

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor's degree in a related field (e.g., Life Sciences, Business Administration); advanced degree preferred.
• 10+ years of experience in clinical operations and vendor and contract management.
• In-depth knowledge of clinical trial management and vendor outsourcing.
• Proven track record of an ability to influence go/no-go decisions as it relates to clinical trial strategies.
• Proven track record of successfully negotiating and managing CRO contracts.
• Experience in oncology clinical trials, particularly for phase I to III studies.
• Strong familiarity with regulatory requirements and compliance in clinical research at a global scale (FDA, EMEA, APAC, etc.).
• Strong problem-solving and decision-making abilities.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent organizational, communication, and leadership skills.
• Ability to multitask and thrive in a fast-paced environment.

Job Type: Full-time Benefits:·         401K·         Medical insurance·         Dental insurance·         Vision insurance·         Supplemental disability insurance plans·         Flexible schedule·         Life insurance·         Flexible vacation·         Sick time·         Incentive stock option plan·         Relocation assistance Schedule:·         Monday to Friday Work authorization:·         United States (Required) Additional Compensation:·         Annual targeted bonus X% Work Location:·         On site (San Diego, CA) EQUAL OPPORTUNITY EM