THE OPPORTUNITY
Vir Biotechnology is looking for an Associate Director, Clinical Transactional Counsel to manage the drafting, review and negotiation of clinical site agreements and vendor contracts. You will report to the Vice President, Strategic Transactions 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.
This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.
WHAT YOU'LL DO
- Direct negotiation, and oversight of negotiations, of clinical study agreements (including clinical trial agreements, confidentiality agreements and related contracts) and clinical vendors agreements (including master service agreements, MTAs and SOWs) in accordance with established development timelines
- End-to-end management of the clinical trial agreement process and strategy for global, multi-site 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 country specific 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 clinical trial agreement 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 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
- JD and 8+ 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
