Company Overview
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
Senior Scientist, Toxicology will implement comprehensive plans to support optimal nonclinical programs for candidate drugs in all stages of development from early screening assays to submission of NDA/BLAs. In this role, they will lead the implementation of toxicology plans for multiple programs, enabling the optimal clinical development of candidate drugs. This role reports to the Associate Director, Nonclinical Outsourcing, Toxicology.
Responsibilities
- Proactively executes plans to provide stage specific data for all assets from late-stage research through regulatory submission for drug approval.
- Ensures high-quality and on-time authorship of nonclinical protocols and reports for regulatory submissions (such as IBs, CTDs, INDs, BLAs).
- Actively partners with other functions and departments to ensure that programs are progressed seamlessly through the development process.
- Participates in assessment of in-license assets to provide datasets required for decisions by management.
- Represents the function at internal and external meetings, providing clear assessment of timelines and costs, including complex visualizations, to effectively communicate the impact to pipeline assets.
- Periodic travel to CROs and collaborators to monitor studies and ensure the quality and consistency of study conduct and data generation.
- Actively participates in functional meetings.
Qualifications
- Masters or equivalent degree in a relevant scientific discipline. A Baccalaureate or equivalent degree and relevant experience may substitute for the education requirements for this position.
- 5+ years' experience in pharmaceutical/biotechnology industry, including GLP experience.
Knowledge and Skills
- Demonstrated experience supporting regulatory compliant nonclinical development plans, with excellent working knowledge of the study design, contracting, and implementation process with external (CRO) as well as internal partners. Engagement in cutting edge technologies which improve decision making and align with partners.
- Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment.
- Demonstrated experience in integrating the 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.
- Strong planning and organizational skills with ability to work effectively and cooperatively in a team environment under significant time pressure.
- Demonstrated attention to detail and consistent ability to operate with accuracy and quality.
- Monitors, tracks and communicates study milestones throughout departments.
- Experience with 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.
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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