VP, Regulatory Affairs Strategist

1 week ago

San Francisco, California, United States Tbwa ChiatDay Inc Full time
About the Role

We are seeking a highly experienced and skilled VP, Regulatory Affairs Strategist to join our team at insitro. As a key member of our leadership team, you will be responsible for developing and implementing global regulatory strategies to support the development of multiple therapeutics and diagnostics.

Key Responsibilities
  • Regulatory Strategy Development: 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.
  • Global Regulatory Leadership: 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.
  • Regulatory Risk Management: 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.
  • Regulatory Policy Influence: Influence emerging regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagement.
  • Regulatory Expertise: Interpret regulatory requirements for project and executive teams, board of directors, and scientific advisory board.
Requirements
  • Advanced Degree: Advanced degree in life sciences, technology, chemistry or related discipline, with specialized (e.g., M.S.) degree in regulatory science, or equivalent practical experience.
  • Regulatory 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.
  • Communication and Collaboration: Capable of communicating and collaborating with people of diverse backgrounds and job functions, with a demonstrated track record of collaborating with diverse stakeholders, including other clinical, translational, computational, and life scientists.
  • Interpersonal Skills: Strong interpersonal skills that motivate others to excel and achieve their very best.
Compensation and Benefits

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
  • 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

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