Job Description

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 therapies—including radiopharmaceuticals and early-stage antibody–drug 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 You’ll Do

• Lead regulatory strategy for radiopharmaceutical and ADC programs entering early clinical development
• Drive preparation, authorship, and submission of INDs—including 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

• Bachelor’s degree in a scientific discipline; advanced degree (MS, PharmD, PhD) preferred
• 7–10+ years of biotech/pharma industry experience, with at least 5+ in Regulatory Affairs
• Strong experience preparing early-phase INDs (required)
• Background in radiopharmaceuticals, oncology, nuclear medicine, or targeted radiation highly preferred
• Experience supporting complex modalities such as ADCs, radio-conjugates, or biologics strongly valued
• Solid understanding of clinical pharmacology, trial design, and nonclinical requirements for oncology INDs
• Excellent communication skills with the ability to influence across R&D, clinical, and executive teams
• Demonstrated ability to lead submissions in fast-paced, growing, or early-stage environments
• Highly organized, solutions-oriented, and proactive in anticipating regulatory needs

What You’ll Receive

• Competitive base salary + performance bonus + equity
• Medical, dental, vision, and disability coverage
• Generous PTO, sick time, and paid holidays
• Hybrid work environment with flexibility for highly qualified remote candidates
• A mission-driven culture grounded in scientific excellence, collaboration, and patient impact

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 you’re 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.

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