Clinical Contracts and Budgets Manager at Viking Therapeutics, Inc. – San Diego, California
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About This Position
The Clinical Contracts and Budgets Manager will be responsible for managing the lifecycle of clinical contracting and site budgeting. This role requires strong financial acumen and hands-on expertise with Master Service Agreements (MSAs), Clinical Trial Agreements (CTAs) Statements of Work (SOWs), and related clinical agreements. Working in close partnership with Clinical Operations, Clinical Development, Legal, and Finance as well as external vendors, this role ensures that budgets and contracts are aligned with protocol requirements, study timelines, and financial objectives. The ideal candidate is a detail-oriented professional who proactively assesses risk, challenges assumptions, and helps ensure agreements are legally compliant, and operationally executable.
Essential Duties and Responsibilities
The main responsibilities of this role include:
- Partner with Clinical Operations, Clinical Development, Finance and external vendors to develop study-specific site budget templates and negotiation parameters.
- Review and support negotiation of clinical trial site budgets in alignment with fair market value (FMV) guidelines and study specific parameters.
- Support contract negotiations within approved financial and legal parameters.
- Manage the end-to-end contract lifecycle, including Clinical Trial Agreements (CTA), Master Services Agreements (MSA), Statements of Work (SOW), amendments, and change orders.
- Partner with Clinical Operations and Legal to develop site contracting timelines, documents, track progress and provide regular updates to study teams and internal stakeholders.
- Support the site clinical trial agreement (CTA) development timeline.
- Partner closely with Clinical Operations and Legal on contract review, redlines, risk assessment, and resolution of contractual issues.
- Review and analyze budgets, payment terms, milestones, and pass-through costs to ensure accuracy and alignment between executed contracts, approved budgets, and forecasts.
- Monitor and track contract and budget changes that impact scope, cost, or timelines; escalate risks and issues as appropriate.
- Utilize internal and external benchmarking data to perform site budget analyses and support negotiation recommendations.
- Responsible for Clinical Operations vendor sourcing and evaluation activities including drafting, submitting, and managing RFI/RFP, proposal comparison and analysis, coordination of bid defenses and proposal review meetings, and communication of vendor award and non-award notifications.
- Partner with Clinical Compliance, QA, and Clinical Development to ensure vendor selection processes are efficient and compliant with ICH GCP E6, and oversee vendor risk mitigation per ICH GCP E6 guidelines.
- Responsible for partnering with Finance, Legal, and Clinical Operations to manage clinical vendor contract lifecycle, including Statement of Work (SOW), Change Orders, Rate Cards, and Functional Service Provider (FSP) models.
- Partner with Legal and Finance colleagues to establish Confidentiality Agreements and Master Service Agreements.
- Support study-level budgeting, forecasting, and variance management activities as needed.
- Other duties as assigned.
Education and Experience
- BS/BA degree and a minimum of 6 years of relevant and progressive experience.
- 4+ years of direct clinical site budget negotiation experience
Knowledge and Skills
- Deep understanding of the drug development process and cross-functional responsibilities.
- Knowledgeable in the use of industry benchmarking data sets (e.g., Grantplan, etc.).
- Proven track record of supporting financial processes, including budgeting/forecasting and variance management.
- Effective and collaborative problem-solving skills.
- Ability to multi-task within and across projects and prioritize and manage timelines effectively.
- Strong interpersonal, communication and presentation skills to be able to engage with all levels both internally and externally.
- Able to apply good judgement and professional expertise in new situations.
- Experience in pharmaceutical/biotech industry required.
- Experience with complex trial designs preferred.
- Highly accountable, adaptable, and detail-oriented.
- Able to work independently or on teams in a fast-paced environment.
VIKING THERAPEUTICS
Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Notice to Agency and Search Firm Representatives
Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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Job Location
Job Location
This job is located in the San Diego, California, 92121, United States region.