We are seeking a strategic and scientifically rigorous leader with deep expertise in preclinical DMPK, including semi-quantitative and traditional DMPK modeling approaches, and with additional experience in clinical pharmacology considered a strong plus to support upcoming clinical development needs.

Responsibilities:

• Develop and implement preclinical DMPK & clinical pharmacology strategies that advance SAIL’s programs through IND-enabling activities and into early clinical development.
• Serve as the DMPK subject matter expert on cross-functional program teams, providing scientific leadership across ADME, distribution, metabolism, PK, PK/PD relationships, and dose-exposure-response understanding.
• Lead semi-quantitative, mechanistic, and traditional DMPK modeling efforts, including human dose projection, PK/PD interpretation, and translational assessments to inform candidate selection and development decisions
• Oversee the design, execution, and interpretation of preclinical DMPK studies, ensuring scientific rigor, data quality, and alignment with program objectives.
• Lead and manage execution of all IND-enabling DMPK activities, including PK, PK/PD, bioanalytical strategy, and modeling and simulation efforts to support FIH dose selection.
• Draft and contribute to key regulatory documents such as IND summaries and reports, Investigator Brochures, and submission materials. Serve as a primary contact for resolving pharmacology-related regulatory questions and preparing response documents.
• Support clinical pharmacology strategy and execution, including contribution to clinical dose rationale, exposure-response assessments, and early clinical study design as programs enter the clinic.
• Manage external vendors and CROs supporting DMPK and modeling activities, ensuring delivery within scope, timelines, and budget

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 preclinical DMPK programs that progressed to IND and early clinical development
• Hands-on experience with semi-quantitative and traditional DMPK modeling approaches
• Clinical pharmacology experience (e.g., FIH dose selection, exposure-response analysis, clinical PK interpretation) preferred, but not required
• Experience supporting regulatory interactions related to DMPK and clinical pharmacology
• Self-motivated with strong initiative and deadline-driven execution
• Ability to identify risks, propose mitigation strategies, and influence program direction
• 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

Salary Range: $195,000 - $285,000

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.