Sr Director/VP Clinical Operations

The Opportunity

insitro is using machine learning to yield 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 SD/VP Clinical Operations is an opportunity to directly improve patients' lives by leading clinical trial operations across four areas, each informed by machine learning: metabolism, neurology/neurodegeneration, 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 build and then lead the clinical operations function at insitro, including by developing and implementing clinical operations strategies to support the development of multiple therapeutics and diagnostics. How to identify the right patients, enroll them efficiently, and obtain, validate, and document robust clinical data to inform decision making remain key challenges for clinical trial operations. Therefore, you will be at the forefront of designing and implementing innovative, accelerated operations approaches, and you will have the opportunity to utilize insitro's machine learning expertise to achieve operational excellence.

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 health authorities.

This is an excellent opportunity for a seasoned clinical operations professional who is passionate about using their skills and experience to accelerate the drug development process and bring better drugs to the patients who can benefit most.

Responsibilities

• Build and lead the clinical operations function (current focus is IND/CTA through clinical proof-of-concept) across metabolic disease, neurodegeneration, and oncology. Our clinical trials will utilize laboratory and digital biomarkers, diverse therapeutic modalities, innovative regulatory pathways, and AI/ML approaches.
• Be accountable for end-to-end clinical operations strategy, good clinical practice, adherence to regulatory standards, site and regulatory authority clinical operations documents and interactions, and clinical trial CRO selection and oversight.
• Develop standard operating procedures, establish staffing and resourcing needs, and ensure the efficient delivery, transfer, and reporting of high-quality, source-verified clinical trial data.
• Serve as the clinical operations lead for the initial clinical-stage asset(s); over time, build and manage a focused, effective team of study team leads/study managers to match our growing pipeline.
• Collaborate with key counterparts in clinical, regulatory, computational, and translational medicine.

About You

• BA/BSc/MSc in life sciences, health-related field, or equivalent practical experience..
• 10+ years of experience in clinical operations in biotechnology and/or pharmaceutical industries, directly as a clinical operations lead and in a leadership/management role to deliver therapeutic(s) and diagnostic biomarker(s) in at least one of our key therapeutic areas (metabolic disease, neurology/neurodegeneration, oncology) to the clinic from FIH through proof-of-concept to NDA/BLA submission.
• Exposure to AI/ML methods is very nice to have.
• Key competencies: demonstrated understanding of regulations and guidelines governing clinical trial operations, including diagnostic and device development, good clinical practice, clinical trial design and execution, the patient journey, clinical pharmacology, biostatistics, clinical operations as they relate to clinical operations, and 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.
• Passion for providing better medicine to patients in need

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $240,000 - $300,000. 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 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