Senior Director @ Vir Biotechnology

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. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies.

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.

THE OPPORTUNITY

Vir Biotechnology is seeking an experienced Senior Director, within the Global Pharmacovigilance & Risk Management (PVRM) Medical Safety department. The Senior Director will provide medical expertise in signal management, risk management, and monitoring the safety profile of Vir products (from First-In-Human through post-marketing). You will perform as a leader who is collaborative, a self-starter, and able to work in a matrixed environment.

This is a remote position. Vir only supports employees within the United States and reserves the right to approve work locations.

WHAT YOU’LL DO

Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks; to provide strategies for risk management/mitigation and develop Risk Tracking Document and RMP; to evaluate the Benefit-Risk profiles of Vir products
Contribute to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms, IB Reference Safety Information, Publications, and other relevant documents
Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations
Support inspection readiness and provide expertise in audits, inspections, and CAPAs
Perform medical review of Individual Case Safety Reports
Perform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety information
Provide leadership in regulatory authority interactions regarding safety and risk management
Support the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities
Assist in the maintenance of Global PVRM related cross-functional SOPs in compliance with global safety regulations and guidelines and lead corporate initiatives and inspection readiness

WHO YOU ARE AND WHAT YOU BRING

Medical degree (MD/DO), PharmD, or equivalent required, with at least 2 years of experience in clinical/medical practice
10+ years of related experience; experience in global pharma/biotech is preferred
Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
Experience with signal detection process and managing safety information from clinical development and post-marketing sources
Experience leading cross-functional SRMTs teams.
Experience with global regulations and ICH guidance governing pharmacovigilance and risk management
Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding

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WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $250,000 to $329,000. 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!

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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.

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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Senior Director

Global Pharmacovigilance & Risk Management, Medical Safety

Vir Biotechnology

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