VP, Regulatory

Job Description

• Build and lead the entire regulatory function across neurology/neurodegeneration, metabolic disease, oncology, and diagnostics. This will include diverse therapeutic modalities (e.g., small molecules, biologics, oligonucleotides) and novel laboratory and digital biomarkers, developed internally and in-licensed; all development stages (focus is IND/CTA through clinical proof-of-concept); diverse regulatory pathways; and regulatory elements of key drug development functions (e.g, clinical, chemistry, biologics, and device manufacturing controls, nonclinical). • Design and oversee innovative regulatory strategies to enable objective, data-driven go-no-go decisions efficiently and shorten the development cycle in the face of an evolving regulatory landscape. • Serve as global regulatory lead for the initial clinical-stage asset(s); over time, build and manage a focused, effective team of global regulatory leads to match our growing pipeline. • Be accountable for end-to-end global regulatory strategy, good clinical practice, and adherence to regulatory standards. This includes identification and mitigation of regulatory risks, creation, review, assembly, and submission of regulatory documents at all stages of development, and oversight of engagements with global health authorities and ethics committees. • Influence emerging regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagement. • Interpret regulatory requirements for project and executive teams, board of directors, and scientific advisory board.

Qualifications

• Advanced degree in life sciences, technology, chemistry or related discipline, with specialized (e.g., M.S.) degree in regulatory science, or equivalent practical experience.. • 10+ years of experience in regulatory affairs in biotechnology and/or pharmaceutical industries, directly as regulatory lead and in a leadership role to deliver therapeutic(s) and diagnostic biomarker(s) in our key therapeutic areas (metabolic disease, neurology/neurodegeneration, oncology) to the clinic from FIH through proof-of-concept to NDA/BLA submission. Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, with exposure to AI methods, is very nice to have. • Key competencies: demonstrated understanding of regulations and guidelines governing drug, diagnostic, and device development, good clinical practice, clinical trial design and execution, the patient journey, clinical pharmacology, biostatistics, clinical operations, application of computation to drug development. • Capable of communicating and collaborating with people of diverse backgrounds and job functions, with a demonstrated a track record of collaborating with diverse stakeholders, including other clinical, translational, computational, and life scientists. • Strong interpersonal skills that motivate others to excel and achieve their very best.

Benefits

• 401(k) plan with employer matching for contributions • Excellent medical, dental, and vision coverage (insitro pays 100% of premiums for employees on our base plans), as well as mental health and well-being support • Open, flexible vacation policy • Paid parental leave • Quarterly budget for books and online courses for self-development • Support to occasionally attend professional conferences that are meaningful to your career growth and development • New hire stipend for home office setup • Monthly cell phone & internet stipend • Access to free onsite baristas and cafe with daily lunch and breakfast • Access to free onsite fitness center • Commuter benefits