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.
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
- 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
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.
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Skills Required
- Juris Doctor (JD) degree
- 8+ years' experience in the pharmaceutical or life sciences industry with extensive clinical contract negotiation experience
- Experience authoring, negotiating, and managing clinical trial agreements (CTAs), master service agreements (MSAs), MTAs, SOWs and related governing documents
- Proven ability to provide clear, practical, business-oriented guidance on clinical contracting throughout the contracting lifecycle
- Knowledge of relevant local/country regulations affecting clinical trial agreements
- Experience supporting clinical trials at start-up, maintenance, and close-out stages
- Knowledge of outsourcing and procurement processes, including purchase orders and vendor invoice review
- Ability to work on-site in San Francisco approx. 3 days per week (hybrid)
- Must currently be authorized to work for any employer in the U.S.; employer will not sponsor visas
What We Do
Vir Biotechnology, Inc. (in Europe, Humabs BioMed, https://bit.ly/46lQGN2) is an immunology company focused on powering the immune system to address unmet patient needs in infectious disease and beyond. Our powerful R&D engine combines our proprietary monoclonal antibody (mAb) platform with machine learning and artificial intelligence-enhanced capabilities, enabling us to engineer our rich database of human antibodies and deliver transformative medicines for diseases with significant global burden. Our current pipeline consists of multiple clinical candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus, including a potential functional cure for chronic hepatitis B and treatment for chronic hepatitis delta. Our portfolio of broad, potent investigational monoclonal antibodies also targets influenza A and B viruses, COVID-19, respiratory syncytial virus/human metapneumovirus and human papillomavirus, and our investigational T cell vaccine aims to prevent HIV. Explore our full pipeline: https://bit.ly/3tr7FPm We collaborate with some of the world’s leaders in industry as well as government agencies and non-profit organizations enabling us to rapidly advance cutting-edge scientific discoveries and innovative technologies with the potential to benefit people around the world. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™. Join us as we pursue our mission to transform lives. It has come to our attention that there have been various recruitment scams targeting job seekers on LinkedIn. Vir Biotechnology, Inc. is committed to your privacy and will never request sensitive personal information including banking details through email, text message, social media or video software platforms. We also will never request a financial commitment from a candidate as part of the application process. Learn more about Vir’s recruiting process: https://bit.ly/461EgJN
