(Senior) Medical Director, Physician and Translational Lead for Metabolism

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, Physician and Translational Lead for Metabolism 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