Associate Director, Bioanalytical

Job Title: Associate Director, BioanalyticalCompany: Immunome, Inc.Location: Bothell, WA

Company OverviewImmunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.

Position OverviewThe Associate Director, Bioanalytical will develop and implement comprehensive plans to support bioanalysis 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 the bioanalytical strategy for multiple oncology programs. This role reports to the ED, Quantitative Pharmacology and Disposition.

ResponsibilitiesDevelop and implement bioanalytical strategy for compounds in preclinical and clinical development; including scientific and technical oversight of bioanalytical method development, troubleshooting, performance, assay transfer; ensure scientific and regulatory compliance with Identify, develop and maintain working relationships with external vendors to facilitate execution of bioanalytical strategies. Actively partners with other functions and departments to ensure that programs are progressed seamlessly through the development process; ensure bioanalytical subject matter expertise is represented in cross-functional project teams.Author relevant sections of non-clinical and clinical study protocol, analysis plans, reports and regulatory submissions (such as IBs, CTDs, INDs, BLAs); lead response strategy and author responses to bioanalytical related Health Authority inquiriesActively participates in functional senior leadership meetings.Plans for resourcing needs, including recruiting and retaining high quality scientists to enable rapid progression of compounds through the development cycle; managing balance between internally supported vs. externally supported activities.

QualificationsPh.D. in a relevant scientific discipline (analytical chemistry, chemistry, biochemistry or closely related scientific discipline)7+ years' experience in pharmaceutical/biotechnology industry in regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience.Familiarity with current global bioanalytical regulatory guidance.History of hands-on bench-level experience preferred developing and implementing bioanalytical assays in large and small molecule drug development with the ability to help method development and troubleshooting is required.Experience in successful submission of at least one global filing for approval (NDA/BLA).Extensive experience managing relationships with global bioanalytical vendors.Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.

Knowledge and SkillsDemonstrated experience supporting clinical and regulatory development of bioanalytical requirements, including non-GLP, GxP regulations, with excellent working knowledge of the regulatory process. 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 bioanalytical plans to support preclinical and clinical development.Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly.Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities. 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

E/E/OImmunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Salary Band$173,000-$192,000