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Director, Drug Safety Operations/Science and Compliance
IDEAYA BiosciencesSouth San Francisco, United Statesfull_timeVerifiedPosted 13 Aug 2024
💰 $251,576/yr($228,302/yr – $251,576/yr)
About the role
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.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:The Director, Safety Operations and Compliance will serve as a safety expert accountable for the oversees planning, implementation, and management of Safety Operations and Compliance activities in support of the Ideaya Biosciences development portfolio, in close collaboration with other Safety and Medical staff.This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies.This position will report to the Vice President of Pharmacovigilance and Patient Safety.This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:The Director, Safety Operations and Compliance will serve as a safety expert accountable for the oversees planning, implementation, and management of Safety Operations and Compliance activities in support of the Ideaya Biosciences development portfolio, in close collaboration with other Safety and Medical staff.This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies.This position will report to the Vice President of Pharmacovigilance and Patient Safety.This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What you'll do:
- Responsible for the strategic planning, implementation, and management of Ideaya Safety Operations activities
- Responsible for leading, supporting, and managing the relationships with the safety vendor(s) to ensure effectiveness, quality, and compliance of outsourced activities
- Ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with the safety vendor, clinical CROs, and Regulatory Operations
- Responsible for safety management plans, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow between CROs, and Ideaya are clearly delineated and followed
- Management of safety staff both full time and contract
- Develop a good cross functional relationship with clinical, data management, regulatory, clinical operations, quality, medical writing, legal and finance
- Make sure the safety remains within the allocated budget for the fiscal year and also provide projected budget every six months
- Responsible for the development and maintenance of Safety Data Exchange Agreements with Ideaya’ s partners and ensures compliance with the agreed upon terms
- Reviews the safety sections of clinical documents, including the safety reporting section of protocols
- Responsible for the development, implementation, and maintenance a Safety quality management system including the identification and authoring of required procedural documents to ensure compliance with global regulations
- Responsible for the development of internal and externa
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