Pathos was founded to revolutionize precision medicine in cancer by harnessing the power of machine learning to transform drug development. Pathos aims to accelerate traditional oncology approaches based upon a comprehensive and integrated data-first strategy to discover and develop drugs for precise biological pathways. Pathos is currently pursuing co-development and in-licensing opportunities to build a portfolio of clinical stage oncology assets, applying its technology to find the right patients and indications, resulting in a highly improved probability of success and faster time to market.

The founding team built and scaled Tempus Labs, an AI-enabled diagnostics company that has built the world’s largest library of clinical and molecular data and an operating system to make sense of it. Through this experience, the founders have seen how precision medicine can transform lives, yet many patients remain who need better therapies. A new approach is needed to change the paradigm of drug development to rapidly serve these unmet needs, highlighting a unique opportunity for Pathos to pursue. We’re looking for other trailblazers who see the world differently and want to forge this new path with us.

Our team is distributed across the US, with an office in New York City. While we still operate with the agility of a startup, we are scaling to advance our platform. 

About the role

The Medical Director/Senior Medical Director of Clinical Development will be a member of the Clinical Development Team, which is responsible for driving the clinical development strategy and execution.  You will have direct responsibility for the design, execution, oversight, and analysis of clinical trials. You will also collaborate with R&D, Translational Medicine, Biomarker, and other cross-functional teams to incorporate the appropriate biomarker studies into the protocol and to correlate clinical and translational findings to drive optimal clinical development. In addition, you will be providing medical and scientific expertise to cross-functional colleagues and play a critical role partnering with the cross-functional asset team to define clinical strategies. You will be reporting to the Head of Clinical Development.

Key Responsibilities

• Medical Monitoring
• Medical review of trial data, including reviewing eligibility data
• Clinical site interactions, including addressing medical questions and providing site education (including safety management), assessment of key safety-related serious adverse events, and approving safety narratives
• Drafting of clinical protocols, along with medical writing & colleagues from Clinical Operations, and providing the medical strategic oversight of protocol development, including study design, targeted patient populations, eligibility criteria, and defining safety risks & mitigation strategies
• Fulfilling GCP and compliance obligations for clinical conduct and maintaining all required training
• Contributing to the Clinical Strategy and Clinical Development Plans for the company’s asset(s)
• Providing oversight and medical accountability for the company’s clinical trials
• Identifying/ building relationships with principal investigators and KOLs on the treatment modality, indication, and novel clinical trial designs and biomedical statistical analyses
• Supporting the executional delivery of clinical studies (e.g., site activation, status of enrollment, adjudication for protocol violations, medical validation/ data clean-up, and as the medical resource for the site staff)
• Interacting with Health Authorities & IRBs/ECs as the Clinical Program Lead
• Drafting and authoring clinical content for CSRs, regulatory reports, briefing books, and submission documents to support closure, clinical narratives, reporting, and filing of the study in partnership with colleagues in clinical operations.
• Staying current on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to the strategy or clinical development plan if needed
• Maintaining a clinical and scientific reputation in the modalities and diseases pertinent to Pathos

Who you are

• MD is required (or a US-equivalent)
• Sub-specialty training in Medical Oncology (preferred)
• 5 or more years of Biotech/Pharma industry experience in Oncology Clinical Trial development and execution, preferably in solid tumors in Phase I/II/III
• Experience in the drug development process, delivering and executing on effective clinical trial plans and protocols
• Leadership and mentorship skills with a hands-on (working leader) approach are required
• Proven ability to lead teams, especially in a remote/virtual environment, and cross-functionally is very important
• Ability to travel up to 30% (domestic and international)