Director, Clinical Pharmacology & DMPK

Title: Director, Clinical Pharmacology and DMPK 

Type: Onsite  

About Sail:

The Role:

SAIL Biomedicines is seeking a Director, Clinical Pharmacology and DMPK to lead and strategize the transition of drug candidates from preclinical research into clinical development. This cross-functional leadership role requires deep expertise in DMPK and clinical pharmacology, strong communication skills, and a balance of strategic thinking with hands-on execution across all stages of drug development.This is an onsite position, with in office expectations tailored to the specific needs of the team, ensuring that responsibilities align with the team's requirements.

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, offering 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).

Qualifications:

• A Ph.D., Pharm D or equivalent degree with at 10+ years of experience within the pharmaceutical/biotechnology industry
• 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
• 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