Senior Director, Drug Safety Operations and Compliance

August 14

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IDEAYA Biosciences

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Synthetic lethality precision medicine oncology company pursuing– an emerging class of precision medicine targets.

Synthetic Lethality and Precision Medicine

51 - 200

💰 $80M Post-IPO Equity on 2022-09

Description

• 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 external (with vendors) key performance indicators and metrics to track performance • Serves as the Safety subject matter expert for internal audits and global inspections • Working knowledge of safety database (ARGUS) and managing all the workflows and experience in database configuration for new studies • Working knowledge of data listing outputs form ARGUS for risk assessment, aggregate reporting’s for DSUR • Experience in managing SAE narrative writing with safety MD’s • Work with safety scientists and safety MDs to prepare for executive safety advisory committee meetings • Support safety data needed for investigator brochure and DSUR • Work with safety scientist, safety MD and data management to ensure that all the data is available from EDC for risk assessment • Maintain safety regulatory calendar for all period submissions • Work with IT to have safety icon on the intranet and structure a safety file folder for all safety related outputs which follows global regulations • Responsible for identifying and following-up on corrective action plans arising from audits and inspections • Responsible for safety inspection readiness activities and preparation and works in collaboration with GCP Quality to align on scheduling of audits for safety vendors • Collaborates with Clinical Quality to ensure awareness and training of appropriate Ideaya personnel to Safety specific policies and SOPs as appropriate • Make sure that all global SOPs are written to maintain compliance with global regulations and partner audits • Responsible for hiring and providing managerial support to direct reports with overall responsibility of leading, training, and mentoring for effective performance • Effectively collaborates with key stakeholders of cross-functional departments to meet corporate and departmental goals

Requirements

• Master’s degree, PharmD, RN in Life Sciences, with10 years' experience in Pharmacovigilance. Oncology experience preferred • Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams • Ability to establish and identify best practices for continuous improvement of case quality, compliance, and process improvement • Demonstrates the ability to handle increasing responsibilities as scope may change relate to team growth and integration efforts cross-functionally • Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with cross-functional colleagues • Ability to work independently, establish priorities, and execute with minimal guidance • Thorough knowledge and experience in safety reporting in both the clinical trial and post-market settings • Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools • Extensive experience participating in inspections/audits and leading efforts around related CAPAs • Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment • Expert knowledge of global safety regulations and guidelines • Excellent interpersonal, communication, analytical, and organizational skills • Strong computer skills desirable, particularly Power Point preparations • Strong and positive people and project management experience • Experience with auditing/planning audits