Senior Director/Vice President, Drug Metabolism and Pharmacokinetics (DMPK)

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 Senior Director/Vice President, Drug Metabolism and Pharmacokinetics (DMPK) is an opportunity to directly improve patients' lives by leading preclinical and clinical DMPK across three main areas, each informed by machine learning - neurology/neurodegeneration, metabolism, and ophthalmology. We are therapeutic modality-agnostic with particular focus on small molecules, biologics, and oligonucleotide modalities.. 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 DMPK function at insitro, including by developing and implementing preclinical and clinical pharmacology strategies to support the development of multiple therapeutics. You will also be at the forefront of implementing new, objective, data-driven, and ML-informed pharmacology approaches. Additionally, this person will also be the non-clinical subteam lead. That team is composed of the DMPK, toxicology, bioanalysis, and external R&D representatives. The non-clinical subteam lead represents this team on the early development project team.

You will report directly to the Chief Medical Officer and work closely with the Chief Scientific 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 translational science conferences and health authorities.

This is an excellent opportunity for a seasoned PK/DM 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

General

• Works to develop an understanding and optimization of a given drug's PK and PD properties, focuses on bioanalytical methods and characterizes the disposition of drugs to optimize their efficacy and safety profiles.

Preclinical

• Acts as DMPK representative on multiple preclinical subteams across oligonucleotide, small molecule and biologics modalities
• Designs and executes (in partnership with internal Bioanalytical and external resources) stand alone in vivo preclinical ADME experiments including metabolite identification
• Partners with Translational Pharmacology, Bioanalytical and Safety Assessment for design and execution of PK/PD and TK in vivo preclinical studies
• Is responsible for establishing internally and through external resources, the appropriate in vitro suite of preclinical assays (including but not limited to metabolic stability, drug-drug interactions, transport, efflux, recycling etc) for the characterization of molecular determinants of ADME properties across small molecules, oligonucleotides and biologics
• Partners with Therapeutic Discovery and technology teams on molecular design and strategies to modulate drug exposure and disposition
• Partners with Data Science/Machine Learning and Cell Biology teams on developing foundational models for efficiently predicting in vivo non-human and human ADME properties of innovative therapeutics

Clinical

• Acts as DMPK representative on clinical subteam and development teams across biologics, small molecules and oligonucleotide modalities
• Responsible for end-to-end Clinical Pharmacology/pharmacokinetic/drug metabolism plans, non-GLP dose range finding and GLP toxicology studies, components of clinical study protocol and reports, analysis and presentation of study participant clinical pharmacology data during study execution, and regulatory documents, and contributes to writing and reviewing responses to and resolving Clinical Pharmacology regulatory queries
• Oversees PKDM bioanalytical methods development and qualifications by responsible team members
• Emphasizes quantitative analysis and modeling to predict human exposure and support dose selection to preclinical and Supports decision-making in lead selection in discovery
• Provides Clinical Pharmacology/PKDM expertise to all disease area project teams including planning, design, and oversight of clinical pharmacology/pharmacokinetic aspects of clinical studies with operational assistance from clinical operations colleagues
• Participates in implementing model-based drug development using quantitative approaches to address scientific questions arising during drug development.
• Provides non-compartmental analysis of PK data and performs PK/PD analyses such as population PK modeling, PK/PD modeling and conducting simulations.
• Plans and performs relevant PK/PD analyses in close partnership with Translational Medicine
• Responsible for integrating knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to improve doses and dosage regimens throughout clinical drug development in collaboration with Statistic.
• Provides recommendations for clinical doses and dosing regimens (including drug-drug interactions, food effect, special group dosing) to the clinical and development teams and in regulatory documentation

About You

• Advanced degree in PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacometrics, Engineering or PharmD with strong written and verbal communication skills
• 10+ years of experience in PK/DM in biotechnology and/or pharmaceutical industries, directly as PK/DMl lead and in a leadership/management role to deliver therapeutic(s) in one of our key therapeutic areas (metabolic disease, neurology/neurodegeneration, ophthalmology) to the clinic from FIH through proof-of-concept to NDA/BLA submission.
• Specific experience with ophthalmology and/or dosing of drugs in body reservoirs/privileged sites in a plus
• Experience interpreting PK and PK/PD data from discovery through clinical stage and integrating this knowledge into the clinical trial and overall clinical program
• Hands-on experience with common software tools for PK and PK/PD analyses (e.g., R, NONMEM, Monolix)
• Exposure to AI/ML methods is a nice to have
• Key competencies: demonstrated understanding of regulations governing preclinical/clinical PK/DM, good clinical practice, clinical trial design and execution, the patient journey, nonclinical and clinical pharmacology, biostatistics, clinical operations as they relate to pharmacology studies, and application of computation to drug development.
• Communicate and collaborate 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 $251,000 - $330,000. 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 as well as mental health and well-being support
• Open, flexible vacation policy
• Paid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent (inclusive of birth, adoption, fostering, etc)
• 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 for employees who are either onsite or hybrid
• Access to free onsite fitness center for employees who are either onsite or hybrid
• Access to a free commuter bus and ferry network that provides transport to and from our South San Francisco HQ from locations all around the Bay Area

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.