Erasca, Inc. logo
Erasca, Inc.

Our mission at Erasca is embedded in our name: To erase cancer.

SVP, Biometrics

Vice PresidentVice PresidentFull TimeRemoteLeadTeam 51-200Since 2020H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

11 days ago

Salary

$350K - $415K / year

Seniority

Lead

Postgraduate Degree15 yrs expEnglishGoogle Cloud Platform

Job Description

SVP, Biometrics

Erasca, Inc.

• 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. • This role requires hands-on execution as well as oversight of internal and external staff. • In addition, this person will represent the Biometrics function on the Erasca leadership team and in cross-functional discussions and decision making. • Build, maintain, and develop a high performing team across Biostatistics, Statistical Programming, 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. • Collaborate with VP, Biostatistics, to ensure statistical analysis and submission datasets meet regulatory requirements. • Collaborate with VP, Statistical Programming & Analysis, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place. • Collaborate with Sr Director, Clinical Data Management, to 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.

Job Requirements

  • 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 and leading and managing highly accomplished function managers.
  • 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, with the ability to tailor communication style to diverse audiences and situations.
  • 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.

Benefits

  • Paid Time Off
  • Holiday
  • 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

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