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 Senior Medical Director, Metabolism, Head of Clinical and Translational Medicine is a unique opportunity to directly improve patients' lives by leading clinical trial design and execution for new therapies and diagnostics for metabolic diseases. 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, execute, and oversee rapid clinical trials of diverse therapeutic modalities and companion digital and laboratory biomarkers from first-in-human through proof-of-concept. The number of drug developers applying machine learning to diagnostic and drug development is increasing. Therefore, you will implement innovative clinical trials of new therapies and diagnostics and influence how machine learning-informed drug development advances at the same time. 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 (~one week per month) in the office. Additional travel will be needed: to clinical sites for site initiation and onboarding; to relevant medical conferences; and to the clinical research organizations we will partner with.

Responsibilities

• Build and lead the clinical function for metabolic disease. This will include diverse therapeutic and diagnostic modalities (e.g., small molecules, biologics, oligonucleotides, novel laboratory and digital biomarkers), developed internally and in-licensed; and all development stages (focus is IND through clinical proof-of-concept).
• As the metabolic diseases clinical expert for the company, use your expertise to bring clinical data to bear directly on our research and computation and vice versa. This includes: playing a key strategic role in integration of patient perspective to inform disease modeling and drug discovery efforts, partnering with colleagues in data science & machine learning (DSML) and corporate development to identify critical data assets and/or commission the generation of data for biomarker discovery in metabolic diseases, and collaborating with DSML colleagues to define machine learning (ML) models for clinical data to inform our understanding of patient trajectory and patient subpopulations and to identify novel endpoints for clinical trials.
• Design and oversee innovative, accelerated clinical trial strategies, including ML-enabled trials, to enable objective, data-driven go-no-go decisions and shorten the development cycle in the face of an evolving regulatory landscape.
• Partner with clinical operations to build a network of clinical trial sites, attract key investigators, and select effective clinical research organizations.
• Serve as global clinical/development lead and medical monitor for the initial metabolic diseases clinical-stage asset(s); over time, opportunity to help build and manage a focused, effective team of global clinical leads to match our growing pipeline.
• Be accountable for the end-to-end clinical development plan, target product profile, clinical components of IND, protocol and amendments, clinical study reports, regulatory information requests, clinical trial translational biomarker plan, and statistical analysis plan.
• In partnership with other key colleagues, oversee clinical manuscripts, abstracts and presentations, presentation of clinical programs internally and externally at investigator meetings, advisory boards, clinical trial sites, and clinical components of regulatory interactions.

About You

• MD or MD-PhD with residency and fellowship training in a specialty related to metabolic diseases (e.g., gastrointestinal/liver disease, obesity, endocrinology). Active US board certification preferred. Technical experience in genetics, molecular biology, metabolism, cellular biology, or equivalent preferred.
• 5-10+ years' experience in clinical development with at least 3-5+ years in biotechnology or pharmaceutical settings leading the design and execution of clinical trials for metabolic diseases from first-in-patient through proof-of-concept. Managed other global clinical leads in the same is preferred for senior director level.
• Experience working with patients, patient data, and biomarker data sets such as proteomics, metabolomics, transcriptomics, imaging.
• Established track record of original contributions to clinical trials, translational medicine, or clinical practice including original publications and/or presentations.
• Key competencies: basic and translational science and physiology of metabolic diseases, patient care, clinical trial design and execution, clinical pharmacology, biostatistics, clinical operations, good clinical practice, regulatory science, applications of computation to medicine.
• Capable of communicating and collaborating with people of diverse backgrounds and job functions, including 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 $260,000 - $350,000. 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

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.