Associate Director, Clinical Transactional Counsel

Vir Biotechnology•San Francisco, CA

13h•Hybrid

About The Position

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN ® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease. PRO-XTEN ® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. 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.

Requirements

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

Responsibilities

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