VP Global Pharmacovigilance

Erascais 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 cancersmost 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.

Essential Duties and 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 Erascas 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 Companys core values policies and all applicable regulations.

Required Education and Experience:

• 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.

The anticipated salary range for this position is $370000 to $390000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry education etcetera. In addition to base salary the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.

Along with our casual collaborative and fun work and the chance to make your mark in our mission to erase cancer Erasca offers a comprehensive and competitive benefits package that includes: 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 and the opportunity to participate in an Employee Stock Purchase Program.

Erasca Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of sex race religion national origin ancestry physical or mental disability protected medical condition genetic information marital status registered domestic partner status age sexual orientation military and veteran status or any other basis protected by federal state or local law or ordinance or regulation.