[Hiring] SVP Biometrics @Erasca

Role Description

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Reporting to the Chief Medical Officer, the SVP Biometrics will be accountable for biometrics activities for all programs from IND-enabling to registration and launch. This includes leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions.

• Build, maintain, and develop a high performing team across Biostatistics, Statistical Programming & Analysis, and Clinical Data Management.
• Ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for all programs.
• 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.
• In collaboration with VP, Biostatistics, ensure statistical analysis and submission datasets meet regulatory requirements.
• In collaboration with VP, Statistical Programming & Analysis, ensure the intended analyses are performed, and analysis data sets and their specifications are in place.
• In collaboration with Sr Director, Clinical Data Management, provide support to clinical study teams on the collection, interpretation and reporting of clinical data.
• 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.
• Represent biometrics in interactions with regulatory agencies and health authorities.
• 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.
• Up to 25% travel may be required, possible international travel.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Qualifications

• Minimum of 15 years relevant experience in the pharmaceutical or biotechnology industry, ideally including both large and small company experience.
• PhD degree in statistics or biostatistics required.
• A hands-on and flexible leader, comfortable as a subject matter expert for biometrics as well as contributing at the leadership team.
• Experience in oncology drug development required, ideally from FIH to registration.
• Direct experience leading and working in Biostatistics required as well as experience leading Statistical Programming and/or Clinical Data Management.
• Extensive knowledge of clinical research methodology and regulatory requirements as they relate to trial design and analysis.
• Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skill, SAS, SDTM, and CDISC.
• Extensive experience negotiating successfully with health authorities.
• Excellent analytical and organizational skills.
• Track record of successfully working within individual protocols and across programs to design, drive, and execute statistical strategy.
• Proven ability to attract, develop, and manage top notch talent including a mix of internal and contingent staff.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Executive leadership skills to educate and influence stakeholders and to add value in strategic business planning and decision-making.
• Effective interpersonal, communication, and influencing skills, including strong writing and presentation skills.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Strong learning orientation, curiosity, and commitment to science and patients.

Requirements

• The anticipated salary range for this position is $350,000 to $415,000.
• The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.

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.
• Opportunity to participate in an Employee Stock Purchase Program.

Company Description

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex, race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.