Functional Area: Safety/Clinical Operations
Job Type: Full Time, office based (Cardiff, CA); Remote may be considered
Required education: BS or advanced degree in physical or life sciences preferred
Area(s) of expertise desired: 3+ years of relevant experience in pharmaceutical or biotechnology industry environment. Relevant global safety reporting experience in oncology and training in GCP/GVP.
ABOUT VIRACTA THERAPEUTICS:
Viracta Therapeutics is private biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.
We are currently seeking a Drug Safety Manager to join our experienced drug development team in Cardiff, CA. Remote candidates may be considered, however, in-house is preferred. He/she will oversee day to day safety and pharmacovigilance activity and contribute to the overall strategy for the organization and/or assigned clinical programs. This team member will provide oversight to relevant CROs and consultants in conjunction with the clinical development leadership. We are seeking a strong team player with experience in oncology drug development, strong communication skills, and ability to contribute to a collaborative interdisciplinary environment.
- Ensure timely safety reporting to regulatory authorities, Independent Review Boards/Ethics Committees and Investigators in Viracta’s clinical trials
- Support preparation for, participating in and ensuring adequate follow-up of safety/pharmacovigilance related audits and inspections.
- Ensure close collaboration and communication with PV vendors on outsourced PV tasks
- Design and review of Safety Management Plans for each ongoing clinical study to ensure compliance with relevant regulations
- Maintain internal SAE and PV Master tracker and review e.g. safety CRO compliance reports
- Review and give input to key study, regulatory and other documents (including but not limited to clinical study protocol and amendments, IBs, master patient information/informed consent forms and clinical study reports)
- BS or advanced degree preferred in related field
- Global experience in oncology
- Superior writing skills.
- Understanding of GXP (GCP and CVP) compliance and ICH guidelines
- Strong computer capabilities, including MS Office and role relevant software systems (e.g. Argus)
- Strong communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment
Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to email@example.com and include the job title in the subject line