Senior Manager, Clinical Contracts

Ensure the successful negotiation and ongoing management of clinical trial-related agreements and serve as the key liaison between Clinical Operations, Legal, Finance, and Accounting departments.

Responsibilities

• Provide comprehensive contract lifecycle management.
• Work closely with Clinical Operations, Legal, Finance, and other internal and external stakeholders to support the timely initiation, contractual term review, negotiation, risk assessment, execution, and administration of contracts.
• Manage tracking of contracts, amendments, and budgets, and provide updates to the project and cross-functional teams.
• Serve as point person for contracts with internal and external stakeholders.
• Support RFx and Vendor Management activities.
• Support internal oversight of site payment management.
• Establish contracting SOPs and guidance documents.
• Actively participate in team meetings to expedite contracts to execution.
• Build and maintain strong relationships with external customers, investigators, and vendors.
• Facilitate contract actions and processes independently and effectively in a dynamic environment with competing priorities.
• Respond promptly and professionally to inquiries from internal team members and external vendors.
• Identify and implement process improvements to enhance efficiency and accountability.
• Ensure compliance with SOPs and regulatory guidelines, addressing QA and audit requests as needed.

Requirements

• Bachelor’s degree required.
• 8+ years of contract management experience within the biotechnology or pharmaceutical industry preferred. Experience within academia or a Clinical Research Organization (CRO) may also be considered based on the overall strength and relevance of the candidate's background.
• Clinical Site Budget experience necessary.
• Strong experience with global Phase 1-3 clinical trials. Oncology clinical trial experience preferred.
• Grant Plan experience a plus.
• Good knowledge of ICH-GCP, pharmaceutical related regulations, and laws.
• Ability to thrive in a fast-paced growing company with minimal direction and ability to adjust to changing priorities.
• Proficiency in Microsoft Excel at an Intermediate level required.

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance

Pay

Competitive base salary ranging from $170,000 to $182,000, stock options, restricted stock units, a stock purchase plan (ESPP), and a target bonus. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.

Schedule

• Monday to Friday
• Onsite in San Diego office preferred; hybrid arrangements may be considered with approval and require a minimum of three days per week onsite.