Head of Regulatory Affairs (Oncology)
Head of Regulatory Affairs (Oncology)
📍 Bay Area, CA (Hybrid)
About the Company
We're partnering with a clinical-stage biotech operating in stealth mode, focused on advancing innovative therapies in oncology. The company is backed by a strong investor syndicate and is entering a critical phase of growth with promising early clinical data and a clear path toward later-stage development.
The Opportunity
This is a foundational leadership hire with direct exposure to executive leadership and the Board. You'll own the global regulatory strategy while staying hands-on-shaping development plans, driving submissions, and building the regulatory function from the ground up.
What You'll Do
- Lead global regulatory strategy across clinical-stage oncology programs (Phase I-III)
- Serve as the primary point of contact with FDA and global health authorities
- Partner closely with executive leadership on development and filing strategy
- Drive INDs, submissions, and regulatory milestones
- Build and scale regulatory infrastructure, processes, and team over time
What We're Looking For
- Proven regulatory leadership experience in oncology (hematology a plus)
- Depth across early through late-stage development
- Strong track record of FDA interaction and regulatory strategy ownership
- Ability to operate both strategically and tactically in a lean environment
- Executive presence with strong cross-functional communication skills
Why This Role
- High-visibility role with direct impact on company trajectory
- Opportunity to shape regulatory strategy at a pivotal stage
- Lean, collaborative team with strong scientific foundation
- Competitive compensation + meaningful equity
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.