Immunome, Inc.
oncology
ExecutiveDirector,EarlyStageProgramTeamLeader
“Executive Director, Early-Stage Program Team Leader at Immunome, Inc.. Skills: regulatory affairs, early-phase drug development, oncology, regulatory filings (INDs, CTAs). tactical and strategic oversight of early-phase and late-phase regulatory activities. design and execution of global regulatory strategies for early-phase development programs”
What You'll Achieve.
ensure compliance and support innovative product development; efficiency, quality, compliance and collaboration
Industry & Context.
proactive approach to solving complex challenges
What They're Looking For.
Must Have
7+ years of experience in regulatory affairs with a emphasis on early-phase drug development, Oncology experience is required, Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs)
Nice to Have
Advanced degree (PhD, PharmD, MS), Experience with immunotherapies or biologics is highly desirable
What You'll Do.
tactical and strategic oversight of early-phase and late-phase regulatory activities
design and execution of global regulatory strategies for early-phase development programs
Provide regulatory guidance to cross-functional teams
Identify and assess potential regulatory risks and develop mitigation strategies
and submit regulatory documents for early and late-phase clinical programs (e.g.
Coordinate and oversee the preparation of technical content
and clinical sections of regulatory submissions
Manage timelines and ensure regulatory milestones are met
Serve as a subject matter expert on regulatory systems (e.g.
overseeing system use in collaboration with IT and Quality
user training and data archiving
Contribute to department infrastructure development by initiating processes targeted towards efficiency
compliance and collaboration
Act as a primary contact for regulatory authorities (e.g.
EMA) for early and/or late-phase development programs
Plan and participate in meetings with regulatory agencies
preparing briefing packages
and coordinating follow-ups
Monitor and interpret regulatory guidelines and communicate implications to internal stakeholders
How You'll Work.
Team & Collaboration
Provide regulatory guidance to cross-functional teams, ensuring alignment with Immunome’s objectives and compliance with regulatory requirements; Work closely with research, development, CMC, and quality teams to ensure seamless regulatory support; Provide regulatory input during protocol development, study design, and data interpretation; Train and mentor team members on regulatory processes and requirements; overseeing system use in collaboration with IT and Quality
Communication Scope
interpersonal and communication skills; experience engaging regulatory agencies; communicate implications to internal stakeholders
Process & Methodology
Proven ability to manage multiple projects and priorities in a fast-paced environment, Manage timelines and ensure regulatory milestones are met
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