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.

Responsibilities

• 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.

Requirements

• 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.

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.

Who You Are

The people who thrive here are operators: deep experts who can specify what needs to happen, orchestrate AI agents to execute at scale, and make high-judgment calls that compound over time. If you have spent your career building and shipping AI systems at scale, this is the environment where that experience becomes a superpower.

Location

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

Pay Range

200,000 - 240,000 USD per year (New York Office)

Skills

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.

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.