Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to be the first company to be ranked at the top of the Deloitte Fast 500 list two years in a row (2023 & 2022).
The opportunity 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.
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.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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, Inc., participates in E-Verify .
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For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Vir Biotechnology, Inc.'s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
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Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Vir Biotechnology, Inc.'s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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