VP, Regulatory Affairs

Key Skills

Aartificial intelligence, Effective communication skills, Machine learning techniques

Job Description

The Opportunity

insitro is using machine learning to yield entirely new, clinically actionable insights into critical unmet needs for patients. We aim to go fast and improve things across the entire drug development process from platform to pipeline to patients and back again.

The VP Regulatory is a unique opportunity to directly improve patients' lives by leading global regulatory strategy across four areas, each informed by machine learning: neurology/neurodegeneration, metabolism, oncology, and innovative companion diagnostics. We are devoted to the effort to make clinical trials more helpful for patients and for drug developers. We believe that by focusing on what's best for patients, we can do what's best for drug development at the same time.

You will develop and implement global regulatory strategies to support the development of multiple therapeutics and diagnostics. The number of drug developers applying machine learning to diagnostic and drug development is increasing, and the regulatory science is catching up in real time. Therefore, you will be at the forefront of implementing and influencing new regulatory policies using objective, data-driven approaches. We view regulatory authorities as partners who want to do what's best for patients just as we do and who are open to new approaches based on data. After all, patients are fighting debilitating, life-threatening conditions right now. We have to do better.

You will report directly to the Chief Medical Officer. This role can be either onsite (3 days per week) in our South San Francisco office or hybrid (~1 week per month) in our office. Additional travel may be needed to relevant medical and regulatory science conferences and health authorities.

Responsibilities

• 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.

About You

• 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.

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $295,000 - $335,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

In addition, insitro also provides our employees:

• 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 attend professional conferences that are meaningful to your career growth and role's responsibilities
• 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

insitro is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams–grounded in a wide range of expertise and life experiences–and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process.