Director of Regulatory Affairs

Direct message the job poster from Vivid Resourcing

Director / Senior Director, Regulatory Affairs – Precision Oncology & Small Molecules

Compensation:
Competitive base salary + bonus + equity

A Boston-based, clinical-stage biotechnology company is developing next-generation precision oncology therapies, including novel small molecules and targeted protein degradation approaches. With multiple programs advancing toward IND and early clinical development, the company is seeking an experienced Regulatory Affairs leader to define regulatory strategy and lead IND execution for complex oncology assets.

This role is ideal for a hands-on regulatory leader who thrives in early-stage environments and enjoys shaping first-in-human development strategies.

• Lead global regulatory strategy for small-molecule and targeted oncology programs entering early clinical development
• Drive IND preparation, authorship, and submission, including Module 2 summaries and integrated CMC, nonclinical, and clinical content
• Serve as the primary FDA point of contact, managing pre-IND meetings, Type B meetings, briefing documents, and regulatory correspondence
• Provide regulatory guidance to discovery, translational, CMC, and clinical teams on development strategy and regulatory expectations
• Build regulatory roadmaps for first-in-class and best-in-class oncology assets
• Oversee IND amendments, annual reports, safety updates, and lifecycle regulatory activities
• Monitor evolving FDA and global guidance related to oncology drug development and innovative small-molecule modalities
• Contribute to internal regulatory processes, submission planning, and scalable RA operations

• Bachelor’s degree in a scientific discipline required; MS, Pharm
  
  D, or PhD preferred
• 8–12+ years of biotech or pharmaceutical industry experience, with 5+ years in Regulatory Affairs
• Proven experience leading early-phase IND submissions (required)
• Background in oncology small molecules, targeted therapies, or novel chemical modalities strongly preferred
• Solid understanding of CMC strategy, nonclinical toxicology, and clinical trial design for oncology programs
• Experience working in fast-paced, early-stage or growth-stage biotech environments
• Strong communication skills with the ability to influence cross-functional and executive stakeholders
• Strategic mindset with hands-on execution capability

• Competitive base salary with performance bonus and equity participation
• Comprehensive medical, dental, and vision coverage
• Generous PTO, sick time, and paid holidays
• Hybrid work model with flexibility for highly qualified candidates
• Opportunity to play a foundational regulatory leadership role on programs with significant patient impact

You’ll be instrumental in advancing first-in-human precision oncology programs targeting cancers with high unmet need. If you enjoy building INDs from the ground up and shaping regulatory strategies for innovative small-molecule therapies, this role offers both challenge and long-term impact.