Senior Director Regulatory Affairs (Sonoma)

Director / Senior Director, Regulatory Affairs Radiopharmaceuticals & ADC Oncology

Location : San Francisco, CA (Hybrid 3 days / week)

Remote considered for candidates with strong radiopharmaceutical or ADC background

Compensation Range : Competitive

About the Role

A rapidly advancing oncology-focused biotech is developing next-generation targeted therapiesincluding radiopharmaceuticals and early-stage antibodydrug conjugates designed for precise tumor targeting. With multiple programs approaching key regulatory milestones, the company is seeking an accomplished Regulatory Affairs leader to guide early clinical development strategy and drive the IND process for complex oncology therapeutics.

This is a high-impact opportunity for someone passionate about shaping first-in-human development in one of the most innovative areas of cancer therapy.

What Youll Do

• Lead regulatory strategy for radiopharmaceutical and ADC programs entering early clinical development
• Drive preparation, authorship, and submission of INDsincluding Module 2 and scientific content across CMC, nonclinical, and clinical sections
• Serve as primary FDA point of contact, managing meeting requests, briefing documents, and regulatory negotiations
• Provide strategic guidance across cross-functional teams (R&D, CMC, Clinical, Program Strategy) on regulatory expectations for complex oncology modalities
• Support development of regulatory roadmaps for first-in-class radiopharmaceutical and ADC assets
• Lead preparation and management of IND amendments, annual reports, and safety updates
• Monitor evolving global regulations impacting radiopharma, oncology, and next-gen ADC development
• Contribute to internal best practices, submission planning, and RA operational excellence

Qualifications

What Youll Receive

Why This Role Matters

You'll play a central role in advancing first-in-human radiopharmaceutical and ADC programs designed to address aggressive cancers with limited therapeutic options. If youre driven by building INDs from the ground up and enjoy shaping regulatory frameworks for emerging oncology modalities, this position offers both challenge and meaningful impact.