What are the responsibilities and job description for the Vice President, Regulatory Affairs & Quality position at Slate Medicines?
About Slate
Slate Medicines is a clinical-stage biotechnology company committed to advancing innovative new therapies that may broaden the treatment paradigm and potentially improve outcomes for people with migraine and other headache disorders. Slate is advancing a portfolio of potentially best-in-class therapeutics, led by SLTE-1009, a clinical-stage anti-PACAP/VIP monoclonal antibody designed to enable subcutaneous, infrequent dosing.
We're looking for a VP, Regulatory Affairs & Quality to build both functions from the ground up and serve as our primary voice with the FDA. Because our mechanism has no approved precedent, this person will help define the regulatory path rather than follow one, while putting in place the regulatory and quality infrastructure a company heading into late-stage development needs.
The Role
- Own end-to-end regulatory strategy from nonclinical through BLA, including IND/CTA filings, lifecycle management, labeling, pediatric plans and ex-US (EMA/MHRA) strategy
- Serve as primary contact with FDA and other health authorities, leading pre-IND, Type B/C and End-of-Phase-2 meetings
- Build and defend the scientific and regulatory case for a novel mechanism, including alignment on Phase 3 endpoints, population and dosing
- Own CMC regulatory strategy for a monoclonal antibody, including comparability, immunogenicity and oversight of CDMO activities
- Establish safety governance and pharmacovigilance, including IND safety reporting, DSURs and the regulatory interface with the DSMB
- Set quality strategy and GxP compliance (GCP, GLP, GMP), with a particular focus on clinical data integrity for a patient-reported primary endpoint (ePRO/eDiary, 21 CFR Part 11)
- Lead inspection readiness and CDMO/vendor quality oversight, and serve as the executive escalation point for significant quality issues and CAPAs
- Oversee CRO-provided regulatory support and report quality metrics and risks to the CEO and Board
- Grow the function, starting with defining and hiring a Director or Senior Director, Regulatory Affairs
Experience
Required
- 12–15 years of progressive regulatory affairs and/or quality experience in biotech or pharma, including building and leading teams
- Experience taking a first-in-class or novel-mechanism product through FDA without class precedent, including resolving a substantive scientific disagreement with a review division
- Hands-on IND experience and direct leadership of FDA meetings, including at least one End-of-Phase-2 or equivalent late-stage interaction
- Biologics experience (monoclonal antibody or comparable modality), including CMC strategy, comparability and immunogenicity
- A track record building a regulatory and/or quality function at a small or early-stage company, including hiring and managing quality leaders
- Working knowledge of GCP, GLP and GMP sufficient to set strategy and oversee a hands-on quality team
- Experience working within a CRO-managed monitoring model
- Bachelor's degree required; advanced degree (MS, PharmD, MD or PhD) strongly preferred
Preferred
- Neurology, migraine or headache development experience, especially with patient-reported diary endpoints
- ePRO/eDiary validation and clinical data integrity experience in outpatient trials
- Experience at a company going through IPO or public-company readiness
- Regulatory Affairs Certification (RAC) or equivalent