Responsibilities:

• Develop and implement preclinical DMPK & clinical pharmacology strategies that advance SAIL’s programs through development and regulatory approval.
• Act as the go-to DMPK & Clinical Pharmacology expert within cross-functional teams, drive scientific strategies and provide insights across all stages of development—ranging from distribution, metabolism, PK/PD modeling, dose projection and selection to exposure-response relationships and optimization plans.
• Oversee the planning, conduct, and analysis of pre-clinical DMPK and clinical pharmacology studies, ensuring high scientific rigor and alignment with program needs.
• Lead and manage execution of all DMPK IND-enabling studies—including PK, PK/PD, population modeling, and human dose projection and simulation efforts—to inform clinical decisions and support regulatory documentation.
• Draft and contribute to key regulatory documents such as IND summaries and reports, labeling, Investigator Brochures, and submission materials. Serve as a primary contact for resolving pharmacology-related regulatory questions and preparing response documents.
• Write and review Clinical Pharmacology Plans, data summaries, and applicable sections of Clinical Study Reports.
• Direct external vendors and CRO partnerships, ensuring deliverables stay within scope and budget. Handle contract approvals and invoice management.
• Contribute to business development through scientific due diligence and assessment of new R&D opportunities in precision drug targeting (PDT).

Required Qualifications:

• Bachelor’s degree with 15+ years of experience within the pharmaceutical/biotechnology industry, or a PhD/PharmD with 10+ years of experience within the pharmaceutical/biotechnology industry

Preferred Qualifications:

• Proven success leading and managing preclinical DMPK studies that led to successful IND filing and experience with clinical pharmacology and pharmacokinetics across all development phases
• Experienced in regulatory interactions, including labeling negotiations
• Self-motivated with strong initiative and deadline-driven execution
• Skilled in proactive issue identification and resolution
• Meticulous attention to detail and effective prioritization under tight timelines
• Strong presenter, able to communicate clearly across all organizational levels
• Capable of setting objectives, adjusting priorities, and providing actionable feedback
• Sound judgment aligned with broader R&D strategy context
• Diplomatic and influential communicator
• Excellent interpersonal, written, verbal, analytical, and organizational abilities
• Effective manager of external consultants and vendors
• Recognized thought leader to shape cross functional scientific and strategic decisions

Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.