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Overview
Director, Safety Science at IDEAYA Biosciences. Location: South San Francisco or San Diego, CA. This role reports to the Vice President of Drug Safety and will lead safety monitoring for investigational and marketed products, ensuring compliance with corporate strategies and regulatory standards. IDEAYA Biosciences is a precision medicine oncology company focused on discovery, development, and commercialization of transformative therapies for cancer. Our approach combines small-molecule drug discovery, structural biology, and bioinformatics with translational biomarker validation to develop targeted therapies. IDEAYA is committed to advancing precision oncology therapies to improve clinical outcomes for patients with cancer. Location-based on-site requirement: four days per week at the office per company policy. Non-Solicitation Policy: IDEAYA’s policy prohibits agencies and recruiters from contacting IDEAYA employees. All recruiting decisions are managed by internal Human Resources. External agencies and recruiters should direct communication to humanresources@ideayabio.com and email interest once. Position Summary
We are seeking a Director of Safety Science to join the IDEAYA team, reporting to the Vice President of Drug Safety. This role leads safety monitoring for investigational and marketed products, ensures compliance with regulatory standards, and oversees safety deliverables, risk management, and safety analyses. The position oversees Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and regulatory safety documents (e.g., PBRERs, DSURs, NDAs). It involves cross-functional collaboration on signal detection, risk management, and benefit-risk assessments, while maintaining expertise in drug safety and regulatory trends. Additional duties include vendor oversight, process improvements, and participation in audits and inspections. This position is based in South San Francisco or San Diego and is required to be onsite four days per week. What you’ll do
Report directly to the Vice President of Drug Safety and indirectly to the Senior Medical Director of Drug Safety. Lead safety monitoring for investigational and marketed products, ensuring alignment with corporate development strategies. Oversee core safety deliverables, including safety governance, signal detection/management, periodic/aggregate reporting, and case processing. Supervise and mentor all safety scientists, fostering a collaborative and high-performing team. Conduct safety analyses using case series, data summaries, adverse event trends, and clinical/post-marketing data. Review medical and scientific literature for signal detection and aggregate reporting. Develop and maintain product-specific Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Perform safety data monitoring, interpretation, and analysis. Lead the preparation of safety deliverables, including integrated safety reports and regulatory documents (e.g., PBRER/PSUR, DSUR, PADERs). Provide safety input to clinical documents such as Investigator’s Brochures, study protocols, and clinical study reports. Ensure consistency in safety and risk management content across regulatory submissions. Partner with safety physicians and cross-functional teams on signal detection and risk management activities. Participate in safety governance meetings and contribute to benefit-risk assessments. Author and review safety sections for regulatory packages, including NDAs and responses to health authority queries. Support pharmacovigilance vendor oversight, process improvement initiatives, and inspections/audits. Maintain up-to-date expertise in disease areas, drug safety, regulatory trends, and business practices. Requirements
PharmD, RN, or MD required; advanced degrees (e.g., Master’s) preferred. At least 6 years of experience in patient safety and pharmacovigilance, including team management. More than 3 years of experience authoring and reviewing periodic/ad hoc safety reports and clinical documents (e.g., PSURs, DSURs, Clinical Overviews). Expertise in safety analyses, signal detection, risk management, and health authority responses. Experience with NDA/MAA filings. Strong ability to interpret and integrate safety data. Effective communication skills (written and verbal) for internal and external audiences. Proven leadership in mentoring and managing scientific teams. Must be authorized to work in the United States on a full-time basis. Total Rewards
IDEAYA offers a competitive total rewards package with merit-based salary review, discretionary short-term incentives, and stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company-paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The estimated salary range is $235,000–$290,000, with final offers depending on location, experience, and interview performance. The company provides equal employment opportunities and does not discriminate based on protected characteristics. This position requires onsite work and full vaccination against COVID-19, subject to applicable law and reasonable accommodations. EOE/AA/Vets. Seniority level
Director Employment type
Full-time Job function
Management and Manufacturing Industries
Internet News
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Director, Safety Science at IDEAYA Biosciences. Location: South San Francisco or San Diego, CA. This role reports to the Vice President of Drug Safety and will lead safety monitoring for investigational and marketed products, ensuring compliance with corporate strategies and regulatory standards. IDEAYA Biosciences is a precision medicine oncology company focused on discovery, development, and commercialization of transformative therapies for cancer. Our approach combines small-molecule drug discovery, structural biology, and bioinformatics with translational biomarker validation to develop targeted therapies. IDEAYA is committed to advancing precision oncology therapies to improve clinical outcomes for patients with cancer. Location-based on-site requirement: four days per week at the office per company policy. Non-Solicitation Policy: IDEAYA’s policy prohibits agencies and recruiters from contacting IDEAYA employees. All recruiting decisions are managed by internal Human Resources. External agencies and recruiters should direct communication to humanresources@ideayabio.com and email interest once. Position Summary
We are seeking a Director of Safety Science to join the IDEAYA team, reporting to the Vice President of Drug Safety. This role leads safety monitoring for investigational and marketed products, ensures compliance with regulatory standards, and oversees safety deliverables, risk management, and safety analyses. The position oversees Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and regulatory safety documents (e.g., PBRERs, DSURs, NDAs). It involves cross-functional collaboration on signal detection, risk management, and benefit-risk assessments, while maintaining expertise in drug safety and regulatory trends. Additional duties include vendor oversight, process improvements, and participation in audits and inspections. This position is based in South San Francisco or San Diego and is required to be onsite four days per week. What you’ll do
Report directly to the Vice President of Drug Safety and indirectly to the Senior Medical Director of Drug Safety. Lead safety monitoring for investigational and marketed products, ensuring alignment with corporate development strategies. Oversee core safety deliverables, including safety governance, signal detection/management, periodic/aggregate reporting, and case processing. Supervise and mentor all safety scientists, fostering a collaborative and high-performing team. Conduct safety analyses using case series, data summaries, adverse event trends, and clinical/post-marketing data. Review medical and scientific literature for signal detection and aggregate reporting. Develop and maintain product-specific Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Perform safety data monitoring, interpretation, and analysis. Lead the preparation of safety deliverables, including integrated safety reports and regulatory documents (e.g., PBRER/PSUR, DSUR, PADERs). Provide safety input to clinical documents such as Investigator’s Brochures, study protocols, and clinical study reports. Ensure consistency in safety and risk management content across regulatory submissions. Partner with safety physicians and cross-functional teams on signal detection and risk management activities. Participate in safety governance meetings and contribute to benefit-risk assessments. Author and review safety sections for regulatory packages, including NDAs and responses to health authority queries. Support pharmacovigilance vendor oversight, process improvement initiatives, and inspections/audits. Maintain up-to-date expertise in disease areas, drug safety, regulatory trends, and business practices. Requirements
PharmD, RN, or MD required; advanced degrees (e.g., Master’s) preferred. At least 6 years of experience in patient safety and pharmacovigilance, including team management. More than 3 years of experience authoring and reviewing periodic/ad hoc safety reports and clinical documents (e.g., PSURs, DSURs, Clinical Overviews). Expertise in safety analyses, signal detection, risk management, and health authority responses. Experience with NDA/MAA filings. Strong ability to interpret and integrate safety data. Effective communication skills (written and verbal) for internal and external audiences. Proven leadership in mentoring and managing scientific teams. Must be authorized to work in the United States on a full-time basis. Total Rewards
IDEAYA offers a competitive total rewards package with merit-based salary review, discretionary short-term incentives, and stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company-paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The estimated salary range is $235,000–$290,000, with final offers depending on location, experience, and interview performance. The company provides equal employment opportunities and does not discriminate based on protected characteristics. This position requires onsite work and full vaccination against COVID-19, subject to applicable law and reasonable accommodations. EOE/AA/Vets. Seniority level
Director Employment type
Full-time Job function
Management and Manufacturing Industries
Internet News
#J-18808-Ljbffr