Tbwa Chiat/Day Inc
Director, Toxicology Bothell, Washington, United States
Tbwa Chiat/Day Inc, Baltimore, Maryland, United States,
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview
The Director, Toxicology will develop and implement comprehensive plans to support optimal nonclinical packages for candidate drugs in all stages of development from establishing early screening assays to submission of NDA/BLAs. In this role, they will lead the design, development, and implementation of toxicology plans for multiple oncology programs, enabling the optimal clinical development of candidate drugs. This role reports to the Executive Director, Toxicology. Responsibilities
Author relevant sections of regulatory submissions and clinical protocols (e.g. INDs, IBs, CTDs, BLAs). Proactively develops plans to provide stage specific data for all assets from late-stage research through regulatory submission for drug approval. Executes on plans to provide high quality data to support internal decision making and regulatory submissions. Actively partners with other functions and departments to ensure that programs are progressed seamlessly and efficiently through the development process. Participates in assessment of in-license assets to provide a recommendation to senior management. Represents the function at internal and external meetings, providing clear assessment of timelines, data, and impact to pipeline assets, including complex visualizations, to effectively communicate. Periodic travel to CROs, or coordinate and supervise Study Monitors, to ensure the quality and consistency of study conduct and data generation. Participates in functional meetings. Represents Immunome’s science to external stakeholders. Qualifications
Ph.D., PharmD, MD, or equivalent in a relevant scientific discipline (e.g. biology, toxicology). 10+ years' experience in pharmaceutical/biotechnology industry, preferably with large molecule experience. Experience in successful submission of at least three global filings for Human Trials (NDA/BLA). Knowledge and Skills
Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities. Excellent skills in assessment of the appropriate toxicology experiments to support clinical development at all stages of product development. Demonstrated experience supporting regulatory compliant nonclinical development plans, with excellent working knowledge of the regulatory process. Engagement in cutting edge technologies which improve decision making and align with regulatory partners. Working knowledge of the most advanced exploratory and investigative toxicology methods to interrogate putative target and/or platform-related liabilities. Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment. Demonstrated experience in leading cross-functional teams in the development and execution of biomarker and diagnostics plans to support preclinical and clinical development. Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly. Experience with developing, leading, and executing translational strategies, such as the transition from discovery research into clinical development. Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams. Washington State Pay Range: $200,000 - $260,000 USD E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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The Director, Toxicology will develop and implement comprehensive plans to support optimal nonclinical packages for candidate drugs in all stages of development from establishing early screening assays to submission of NDA/BLAs. In this role, they will lead the design, development, and implementation of toxicology plans for multiple oncology programs, enabling the optimal clinical development of candidate drugs. This role reports to the Executive Director, Toxicology. Responsibilities
Author relevant sections of regulatory submissions and clinical protocols (e.g. INDs, IBs, CTDs, BLAs). Proactively develops plans to provide stage specific data for all assets from late-stage research through regulatory submission for drug approval. Executes on plans to provide high quality data to support internal decision making and regulatory submissions. Actively partners with other functions and departments to ensure that programs are progressed seamlessly and efficiently through the development process. Participates in assessment of in-license assets to provide a recommendation to senior management. Represents the function at internal and external meetings, providing clear assessment of timelines, data, and impact to pipeline assets, including complex visualizations, to effectively communicate. Periodic travel to CROs, or coordinate and supervise Study Monitors, to ensure the quality and consistency of study conduct and data generation. Participates in functional meetings. Represents Immunome’s science to external stakeholders. Qualifications
Ph.D., PharmD, MD, or equivalent in a relevant scientific discipline (e.g. biology, toxicology). 10+ years' experience in pharmaceutical/biotechnology industry, preferably with large molecule experience. Experience in successful submission of at least three global filings for Human Trials (NDA/BLA). Knowledge and Skills
Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities. Excellent skills in assessment of the appropriate toxicology experiments to support clinical development at all stages of product development. Demonstrated experience supporting regulatory compliant nonclinical development plans, with excellent working knowledge of the regulatory process. Engagement in cutting edge technologies which improve decision making and align with regulatory partners. Working knowledge of the most advanced exploratory and investigative toxicology methods to interrogate putative target and/or platform-related liabilities. Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment. Demonstrated experience in leading cross-functional teams in the development and execution of biomarker and diagnostics plans to support preclinical and clinical development. Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly. Experience with developing, leading, and executing translational strategies, such as the transition from discovery research into clinical development. Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams. Washington State Pay Range: $200,000 - $260,000 USD E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr