Vir Biotechnology 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 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.
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 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.
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
- 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
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $235,500 to $329,500. 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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