VP Global Pharmacovigilance

🕒 il y a 5 mois

🏄 California – Distant

🏄 California – Remote

💵 $370 000 - $390 000 / 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

• Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development. • Represent GPV in communication with health and regulatory authorities. • Represent GPV at independent Data Safety Monitoring Committee meetings. • Provide medical oversight of the GPV function including medical review of all cases. • Provide medical input for maintaining REMS, RMP safety monitoring commitments. • In collaboration with other members of GPV, create and maintain a signal detection process for Erasca’s products with a clearly defined signal detection strategy for each asset. • In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments. • Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems. • Provide periodic benefit-risk assessment reports for internal use. • Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities. • Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc). • Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates. • Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis. • Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources. • Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met. • Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors. • Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs. • Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

🎯 Exigences

• Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered. • 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred. • Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications. • In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation. • Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred. • Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred. • In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases. • Direct management experience with proven ability to effectively lead, coach, mentor, and manage others. • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. • Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. • Strong learning orientation, curiosity, and commitment to science and patients.

🏖️ Avantages

• 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 Employee Stock Purchase Program