SVP, Biometrics

🕒 il y a 21 jours

🏄 California – Distant

🏄 California – Remote

💵 $350 000 - $415 000 / an

⏰ Temps Plein

🔴 Expert

👔 Vice-président

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Erasca, Inc.

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2020

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €100 000 000 Post-IPO Equity en 2022-12

Biotechnology • Pharmaceuticals • Science

Erasca, Inc. est une entreprise d'oncologie de précision en phase clinique, engagée dans l'éradication du cancer en ciblant l'une des voies les plus couramment mutées du cancer, la voie RAS/MAPK. L'entreprise est dédiée au développement d'un portefeuille de programmes thérapeutiques sans attachement à un mode de traitement particulier, conçus pour fermer complètement la voie RAS/MAPK, qui affecte des millions de vies dans le monde chaque année. Erasca fait progresser un pipeline solide avec le potentiel de transformer le traitement du cancer et d'améliorer la vie des patients atteints de divers types de cancer. Avec une focalisation sur la science révolutionnaire en oncologie, Erasca vise à apporter un nouvel espoir aux patients et à mener la voie dans les innovations en oncologie de précision.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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