Associate Director, Bioanalytical Mass Spectrometry, ADME

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.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

The Associate Director, Bioanalytical will develop and implement comprehensive plans to support bioanalysis for candidate drugs in all stages of research and development from establishing early screening assays to submission of NDA/BLAs. This person will lead the design, development, and implementation of the bioanalytical strategy for multiple oncology programs. This role reports to the Executive Director, ADME.

Responsibilities

• Develop 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 external vendors
• Identify, develop and maintain working relationships with external vendors to facilitate execution of bioanalytical strategies.
• Actively partner with other functions and departments to ensure that programs 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 inquiries
• Actively participates in functional senior leadership meetings.
• Plan for resourcing needs, including recruiting and retaining high quality scientists to enable rapid progression of compounds through the development cycle; managing the balance between internally supported vs. externally supported activities.
  
  

Qualifications

• A minimum of 5 years of biopharma industry experience with a PhD, 8 with a Master’s, or 10 with a Bachelor’s degree.
• Pharmaceutical/biotechnology industry experience working in a regulated bioanalytical environment, preferably with multiple modalities, is required. This may include small molecule, large molecule and ADC experience, preferably with mass spectrometry.
• History of hands-on bench-level experience 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).
  
  

Knowledge And Skills

• Demonstrated experience supporting clinical and regulatory development of bioanalytical requirements, including non-GLP, GxP regulations, with excellent working knowledge of the regulatory process and mass spectrometry.
• Familiarity with current global bioanalytical regulatory guidance.
• Extensive experience managing relationships with global bioanalytical vendors.
• Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.
• 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.
  
  

Washington State Pay Range

$170,130 - $194,591 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.