VP Global Pharmacovigilance

Erasca•San Diego, CA

10d•$370,000 - $390,000•Hybrid

About The Position

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.

Requirements

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.
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.
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.

Nice To Haves

A mix of large and small company experience highly preferred.
Experience executing clinical trials in China, reporting safety data to China health authorities preferred.

Responsibilities

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.