Director, ToxicologyNew

Immunome • Bothell, WA

419d • $200,000 - $260,000

About The Position

The Director, Toxicology at Immunome will lead the development and implementation of comprehensive toxicology plans for candidate drugs throughout all stages of development. This role is crucial for ensuring optimal clinical development and regulatory submission of oncology programs, requiring collaboration across various functions and departments.

Requirements

• 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).
• Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities.
• Excellent skills in assessment of 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 that improve decision-making and align with regulatory partners.
• Working knowledge of advanced exploratory and investigative toxicology methods.
• Excellent problem-solving skills and ability to oversee multiple projects in a fast-paced environment.
• Demonstrated experience in leading cross-functional teams in biomarker and diagnostics plans development.
• Outstanding interpersonal and communication skills with the ability to communicate complex information succinctly.
• Experience with developing, leading, and executing translational strategies.

Responsibilities

• Author relevant sections of regulatory submissions and clinical protocols (e.g. INDs, IBs, CTDs, BLAs).
• Develop plans to provide stage-specific data for all assets from late-stage research through regulatory submission for drug approval.
• Execute plans to provide high-quality data to support internal decision-making and regulatory submissions.
• Partner with other functions and departments to ensure seamless and efficient program progression.
• Assess in-license assets and provide recommendations to senior management.
• Represent the function at internal and external meetings, communicating timelines, data, and impacts to pipeline assets.
• Travel to CROs or coordinate and supervise Study Monitors to ensure quality and consistency of study conduct and data generation.
• Participate in functional meetings.
• Represent Immunome's science to external stakeholders.

Benefits

• Competitive salary range of $200,000 - $260,000 USD.
• Equal opportunity employer with a commitment to diversity and inclusion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree