Associate Director, Clinical Transactional Counsel at Vir Biotechnology

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Sep, 26

Salary

246500.0

Posted On

14 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Contract Negotiation, Clinical Trial Agreements, Master Service Agreements, Vendor Management, Regulatory Compliance, Risk Assessment, Contract Drafting, Procurement Processes, Legal Guidance, SOW Management, MTA Negotiation, Global Clinical Trial Strategy

Industry

Biotechnology Research

Description

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. 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 #LI-AS1 #LI-Onsite WHO WE ARE AND WHAT WE OFFER The expected salary range for this position is $167,500 to $246,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Vir Biotechnology'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 Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office. Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics. This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment. Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees. For hires based in the United States, Vir Biotechnology, participates in E-Verify. Candidate Privacy Notice

Responsibilities

Manage the drafting, review, and negotiation of clinical site agreements and vendor contracts to ensure compliance with business practices and country regulations. Partner with Clinical Operations and Legal teams to oversee the end-to-end clinical trial agreement process for global trials.