Director, Clinical Science

About the Role

The Director, Clinical Science is a hands-on member of the Clinical Development team, responsible for the day-to-day scientific execution of Pathos oncology programs across active Phase 1 and Phase 2 trials. You own protocol development, data review, clinical document authorship, and site-level scientific support from study startup through closeout.

You will work closely with Clinical Operations, Translational Medicine and Biomarker Science to keep studies running with scientific rigor at every step. You will report to the Chief Development Lead.

At Pathos, AI agents handle literature compilation, document formatting, data extraction, and status tracking. That means you spend your time on the science reviewing data, resolving eligibility questions, sharpening protocols, and making the calls that move programs forward, not on administrative overhead.

What You Will Do

Own protocol development and clinical documents

• Author and own study protocols from first draft through amendments, including study design, eligibility criteria, endpoint selection, and safety monitoring plans.
• Write and maintain Investigator Brochures, informed consent forms, Clinical Study Reports, and briefing documents in partnership with Clinical Operations and Medical Writing.
• Direct AI agents to compile source data, structure document drafts, and run quality checks, then apply your scientific judgment to finalize each deliverable.

Lead data review and monitoring

• Conduct ongoing review of safety and efficacy data across active studies, including eligibility confirmation, protocol deviation assessment, and adverse event review.
• Prepare materials and lead deliverables for data monitoring committees and other clinical review bodies.
• Collaborate with data management on eCRF development, edit check design, and database lock activities.

Support trial execution and site interactions

• Serve as the scientific point of contact for clinical investigators during study startup, conduct, and closeout.
• Provide protocol training at investigator meetings, site initiation visits, and internal study team kickoffs.
• Work with Clinical Operations to identify and resolve site-level issues that affect data quality or enrollment integrity.

Contribute to regulatory submissions

• Prepare scientific content for regulatory authority interactions, including IND amendments, briefing books, and submission dossiers.
• Support responses to Health Authority questions with accurate, well-reasoned clinical and scientific rationale.
• Maintain GCP compliance and audit-ready trial conduct across all assigned programs.

Who You Are

Minimum Qualifications

• MD, PhD or PharmD in a relevant life science discipline required.
• 5 or more years of oncology clinical development experience in biotech or pharma, with direct ownership of protocol design and clinical content authoring.
• Demonstrated track record of delivering study protocols and regulatory documents across Phase 1 and Phase 2 oncology trials.
• Experience in solid tumor oncology; deep familiarity with GCP and applicable regulatory requirements.
• Strong scientific writer with the ability to distill complex evidence into clear, decision relevant documents.

Strongly Preferred

• Experience integrating biomarker and translational strategies into trial design, particularly in genomically defined or molecularly enriched patient populations.
• Comfort working with AI generated analyses, real world evidence, and computational predictions as inputs to scientific and clinical decisions.
• Experience contributing to clinical development plans for multiple concurrent programs in a fast moving organization.
• Familiarity with agentic or AI assisted workflows for document generation, data review, or literature surveillance.

Nice to Have

• Experience designing or contributing to adaptive trial designs or platform trials.
• Direct engagement with Health Authorities on oncology programs, including IND and FDA briefing meetings.

Location

The preferred location for this position is in our New York City HQ, though exceptional remote candidates will also be considered.