Associate Director, Clinical Contracts
San Francisco, United States
Job Description
Vir Biotechnology is looking for an Associate Director, Clinical Contracts to manage the drafting, review and negotiation of clinical related contracts and agreements. You will report to the Senior Director, Business Operations and work with the Clinical Operations team, Legal team and external partners to ensure clinical agreements comply with business best practices and relevant country regulations.
What you’ll do
- Direct negotiation, and oversight of negotiations, of clinical trial agreements, master service agreements and other governing documents in accordance with established development timelines.
- End-to-end management of the clinical trial agreement (CTA) process and strategy for global, multi-site clinical trials.
- Draft and review Letters of Authorization, Powers of Attorney, Material Transfer Agreements, and other development agreements to support vendor and collaborator activities for Vir clinical trials.
- Partner closely with clinical operations, project leadership and additional functional leaders to understand development priorities to support delivery of negotiated contracts.
- Review established templates for clinical trial agreements, confidentiality agreements, master service agreements, consulting agreements and other development agreements to ensure compliance with country regulations, align with business practices, market competitiveness and incorporate lessons learned.
- Review negotiation playbooks to assess recent escalations in site contracts, update terms following negotiations, ensure alignment with market conditions and to include new country specific regulations.
- Collaborate regularly with Legal for contract approval, execution and assessment of risk.
- Co-manage the external partnership with the site contract and budget functional service provider. Participation in bi-weekly status meetings, quarterly governance/KPI reviews and facilitate review and execution of annual service work orders.
Who you are and what you bring
- BS/MS and 12+ years’ experience in the pharmaceutical or life sciences industry; with extensive experience in clinical contract negotiations.
- Demonstrated experience in the authoring, negotiation and management of clinical trial agreements, master service agreements and other governing documents
- Experience providing clear, practical, and business-oriented guidance on all clinical contracting issues throughout the contracting process
- Knowledge of relevant local regulations
- Experience providing contract support at several stages of clinical trials including start-up, maintenance and close-out
- Knowledge of outsourcing and procurement processes to support contract execution, purchase orders and vendor invoice review
- Advanced knowledge of Microsoft Word, Excel, and PowerPoint
- Familiarity with eSignature software including DocuSign and Adobe Acrobat Sign
- This is an onsite role, and you will work a few days each week from our HQ in San Francisco.
"#LI-Onsite"
Who we are and what we offer:
The expected salary range for this position is $168,500 to $246,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees!
Vir Biotechnology (“Vir”) is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
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Career Focus: Admin, Analyst, Business/Commercial Operations
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