Erasca is a clinical-stage precision oncology company seeking an SVP Biometrics to lead biometrics activities for all programs from IND-enabling to registration and launch. The ideal candidate will have excellent technical skills, a track record of developing and mentoring strong teams, and significant experience in all phases of oncology drug development.
Requirements
- Build, maintain, and develop a high performing team across Biostatistics, Statistical Programming & Analysis, and Clinical Data Management.
- Demonstrate technical excellence, delivering advanced biometric strategies across the portfolio.
- Act as the subject matter expert for biometrics, advising senior management, development, and clinical operations teams on current biostatistics methodology and tools in drug development.
- Provide input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for all products.
- Support preparations for interactions with regulatory agencies and provide guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, etc.).
- Review and comment on eCRFs, annotated eCRFs, edit checks documents, and other clinical data management related documents.
- Stay abreast of emerging technologies and concepts related to applied statistical methodology.
- Lead biometrics due diligence in support of business and corporate development activities.
- Establish and further embed biometrics SOPs, processes, and relevant quality management system.
- Ensure appropriate resourcing of the biometrics organization by anticipating needs and filling gaps, as needed, with consultants, contractors, and/or employees.
- Mentor and promote the professional development of Biometrics team members.
Benefits
- Paid Time Off
- Holiday and Sick Leave
- Medical, Dental and Vision Plans
- Short- and Long-Term Disability
- Basic and Voluntary Life/AD&D Coverage
- Flexible Spending Accounts (FSA, HSA, and Commute)
- Critical Illness and Accident Coverage
- Pet Insurance
- Employee Assistance Program
- 401(k) Plan with Erasca contribution
- Employee Stock Purchase Program
