Executive Director, Early-Stage Program Team Leader

Company Overview

Position Overview

This key role will focus on the tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development. The successful candidate will combine hands-on expertise in regulatory affairs with a proactive approach to solving complex challenges in clinical development. 

Responsibilities

Regulatory Strategy Development 

• Contribute to the design and execution of global regulatory strategies for early-phase development programs. 
• Provide regulatory guidance to cross-functional teams, ensuring alignment with Immunome’s objectives and compliance with regulatory requirements. 
• Identify and assess potential regulatory risks and develop mitigation strategies. 

Tactical Implementation 

• Prepare, review, and submit regulatory documents for early and late-phase clinical programs (e.g., INDs, CTAs, amendments). 
• Coordinate and oversee the preparation of technical content, including CMC, non-clinical, 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., Veeva Vault), 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, quality, compliance and collaboration. 

Regulatory Interactions 

• Act as a primary contact for regulatory authorities (e.g., FDA, 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. 

Cross-Functional Collaboration 

• 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. 

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (PhD, PharmD, MS) preferred. 
• 7 years of experience in regulatory affairs with a strong emphasis on early-phase drug development. Oncology experience is required.  
• Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs). 

Knowledge and Skills

• In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.). 
• Proven ability to manage multiple projects and priorities in a fast-paced environment. 
• Strong interpersonal and communication skills, with experience engaging regulatory agencies. 
• Experience with immunotherapies or biologics is highly desirable. 

E/E/O

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

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).