Senior Director, Project Team Lead - Clinical

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, Project Team Lead (PTL, also called Asset Team Lead [ATL]) for Clinical Development is an opportunity to directly improve patients' lives by leading cross functional drug development teams from preclinical development candidate (DC) nomination through Phase 1-2 clinical development including proof-of-mechanism (POM) and proof-of-concept (POC). The PTL is accountable for an end-to-end, cross-functional, and effective integration of the therapeutic molecule strategy, timeline, and risk mitigation.

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 be at the forefront of designing and implementing innovative, accelerated approaches, and you will have the opportunity to utilize insitro's machine learning expertise to achieve drug development and clinical trial 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 PTL 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.

In collaboration with cross-functional teams and working closely with Project and Portfolio Management:

• Cross-functional asset/program leadership is the key part of this role

• Develop and implement clinical program plans

  • Develop vision, strategy, and an end-to-end product plan that accounts for early uncertainties in first-in-human clinical development, define prospective, quantifiable endpoints for effective Go No Go decisions, enable the generation of a clinical data package that could support future registrational trial development and commercialization, and ensure there are adequate resources and technical expertise to meet strategic objectives

  • Identify and manage critical path activities and resources

  • Identify and manage interdependencies and hand‑offs

  • Identify, classify, proactively mitigate, and document (as appropriate) potential risks and roadblocks, including likelihoods, severities, and key mitigations

  • Lead contingency planning

  • Capture and communicate progress; elevate potential delays with proposed solutions

• Direct clinical programs through insitro governance to ensure that:

  • Key drug development functions including preclinical, clinical, technical development/CMC and computational achieve strategic and operational alignment

  • Programs have adequate resources and technical expertise to meet strategic objectives

  • Issues are raised, discussed, and resolved in a timely manner

  • Program/project teams receive insitro Governance decisions in a timely manner

  • Programs adhere to agreed-upon scope, timelines, resources, and budget

• Communication and Culture

  • Accountable for clear and timely communication about the program throughout insitro such as via: agendas, minutes, all-hands and other communication methods

  • Responsible for facilitating Core Team meetings and working with Sub-team Leaders to ensure sub-teams and Core Teams are working in alignment on strategic and operational topics.

  • Present project updates, strategic issues, options, and recommendations to the insitro Governance Committees

  • Ensure clear and effective communication by each asset/project team by overseeing/reviewing presentations and documents to ensure clarity and effectiveness

  • Contribute to team culture and positively influence team environment that encourages authentic, clear communication and a "get stuff done" mentality

• PhD or MD with 8 (Director) or 12+ (senior director) years (including doctoral or MD experience) of relevant experience and/or advanced education in life sciences, health-related field, or equivalent practical experience. Metabolic disease experience is very nice to have

• 5+ years of experience in clinical project/asset team leadership or equivalent role in biotechnology and/or pharmaceutical industries, directly as a PTL 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) from FIH through proof-of-concept in the clinic to transition to late development to NDA/BLA submission.

• 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,…