Vice President, Pharmacovigilance and Safety/ Safety Physician
South San Francisco, CA, USA
Posted on Thursday, December 21, 2023
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.
When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.
IDEAYA is seeking an experienced Safety Physician, VP Level, with extensive background in cancer therapy development. This individual will be responsible for the global safety strategy and oversight of safety medical evaluations for all IDEAYA’s development products. The VP safety physician role will organize and lead the Drug Safety and Pharmacovigilance function, provide medical expertise to the teams, support and collaborate with the Medical Monitors in the conduct of safety assessments and risk management processes and activities for IDEAYA products through the product's life cycle. The successful candidate will ensure proactive safety surveillance, pharmacovigilance and provide the overall product-related safety assessments/decisions.
What you'll do:
- Performs medical review of SAEs, SUSARs and aggregate safety data from all sources in collaboration with medical monitors.
- Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans and other clinical study-related documents.
- Participates in study team meetings as requested or needed.
- Collaborates with PV Operations on PV and Safety functional deliverables.
- Prepares and presents safety data to various teams and Sr. Management, highlights safety concerns/issues and recommends action plans or solutions to the cross-functional decision-making body.
- Leads the planning, preparation, writing and review of portions of aggregate reports.
- Collaborates and develops/updates the RSIs for IBs.
- Contributes to the production of the DSURs and CSRs in data review, analysis and adjudicates benefit-risk assessments of the investigational drugs in collaboration with the Medical Monitors.
- Oversees the signal detection activities, evaluation, and management - performs data analysis to evaluate safety signals and authors analysis results for Safety Assessment Reports.
- Approves searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal detection of each molecule.
- Leads the development of risk management strategies and activities.
- Authors, as needed, various safety documents and health authority responses in collaboration with the cross functional teams such as the Medical Monitors and Regulatory head.
- Supports activities related to new drug applications and other regulatory findings.
- Participates in inspection readiness (i.e. internal process audits and Regulator Inspections) within the scope of a Safety Physician’s role and provides medical evaluations.
- MD degree from an accredited medical school
- Deep understanding of good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines.
- Strong leadership, with proven track record of team building, mentorship and people management
- Collaborates well with cross functional teams in a fast-paced growing company environment.
- Ten or more years of relevant experience in Clinical Safety and Pharmacovigilance in the pharmaceutical industry is required.
- Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Track record of direct participation in registration trials in the bio/pharmaceutical industry
- Previous management and or mentoring experience
- Experience in leading teams and or projects
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.