Executive Director, Early-Stage Program Team Leader
Immunome, Inc.
17 days ago
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview:
Focus on tactical and strategic oversight of early- and late-phase regulatory activities to ensure compliance and support innovative product development.
Responsibilities:
- Contribute to the design and execution of global regulatory strategies for early-phase development programs.
- Provide regulatory guidance to cross-functional teams to ensure alignment and compliance.
- Identify and assess regulatory risks and develop mitigation strategies.
- Prepare, review, and submit regulatory documents for early/late-phase programs (e.g., INDs, CTAs, amendments).
- Coordinate and oversee technical content preparation (CMC, non-clinical, and clinical sections).
- Manage timelines and ensure regulatory milestones are met.
- Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), partnering with IT and Quality for use, training, and data archiving.
- Initiate department processes targeted to efficiency, quality, compliance, and collaboration.
- Act as primary contact for regulatory authorities (e.g., FDA, EMA).
- Plan/participate in regulatory meetings; prepare briefing packages and coordinate follow-ups.
- Monitor and interpret regulatory guidelines and communicate implications to stakeholders.
- Work with research, development, CMC, and quality teams; provide regulatory input during protocol/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; PhD/PharmD/MS preferred.
- 7+ years in regulatory affairs with emphasis on early-phase drug development; oncology experience required.
- Demonstrated experience preparing and submitting regulatory filings (e.g., INDs, CTAs).
Knowledge/Skills:
- In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Ability to manage multiple projects in a fast-paced environment.
- Strong interpersonal and communication skills with experience engaging regulatory agencies.
- Immunotherapies/biologics experience highly desirable.
Focus on tactical and strategic oversight of early- and late-phase regulatory activities to ensure compliance and support innovative product development.
Responsibilities:
- Contribute to the design and execution of global regulatory strategies for early-phase development programs.
- Provide regulatory guidance to cross-functional teams to ensure alignment and compliance.
- Identify and assess regulatory risks and develop mitigation strategies.
- Prepare, review, and submit regulatory documents for early/late-phase programs (e.g., INDs, CTAs, amendments).
- Coordinate and oversee technical content preparation (CMC, non-clinical, and clinical sections).
- Manage timelines and ensure regulatory milestones are met.
- Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), partnering with IT and Quality for use, training, and data archiving.
- Initiate department processes targeted to efficiency, quality, compliance, and collaboration.
- Act as primary contact for regulatory authorities (e.g., FDA, EMA).
- Plan/participate in regulatory meetings; prepare briefing packages and coordinate follow-ups.
- Monitor and interpret regulatory guidelines and communicate implications to stakeholders.
- Work with research, development, CMC, and quality teams; provide regulatory input during protocol/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; PhD/PharmD/MS preferred.
- 7+ years in regulatory affairs with emphasis on early-phase drug development; oncology experience required.
- Demonstrated experience preparing and submitting regulatory filings (e.g., INDs, CTAs).
Knowledge/Skills:
- In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Ability to manage multiple projects in a fast-paced environment.
- Strong interpersonal and communication skills with experience engaging regulatory agencies.
- Immunotherapies/biologics experience highly desirable.