SVP, Biometrics

🕒 May 14

🏄 California – Remote

🏄 California – Remote

💵 $350k - $415k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Erasca, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $100M Post-IPO Equity on 2022-12

Biotechnology • Pharmaceuticals • Science

Erasca, Inc. is a clinical-stage precision oncology company committed to eradicating cancer by targeting one of cancer's most commonly mutated pathways, the RAS/MAPK pathway. The company is dedicated to developing a modality-agnostic portfolio of therapeutic programs designed to thoroughly shut down the RAS/MAPK pathway, which affects millions of lives globally each year. Erasca is advancing a robust pipeline with the potential to transform cancer treatment and improve the lives of patients suffering from various types of cancer. With a focus on groundbreaking science in oncology, Erasca aims to bring new hope to patients and lead the way in precision oncology innovations.

📋 Description

• 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.

🎯 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