Director, Clinical Pharmacology

Role Summary

The Director, Clinical Pharmacology is responsible for overseeing and directing the clinical pharmacology pharmacometric plans, studies, and reports for RAPT clinical development programs, including content for global regulatory submissions such as INDs, CTAs, IBs, BLAs, MAAs, and pediatric plans. Reports to the Chief Medical Officer and serves as a critical interface within the Clinical department and with the research and nonclinical departments.

Responsibilities

• Leads the development and implementation of the strategy for Clinical Pharmacology development activities and communicates strategy and findings to executive management, regulatory agencies, and external peers
• Serves as the Clinical Pharmacology and/or preclinical PKPD lead on core project teams
• Serves as the Clinical Pharmacology lead on core project teams
• Oversees the evaluation of pharmacokinetics/pharmacodynamics, culminating in translation into informative labeling guidance
• Leads and executes the strategic integration of pharmacometric plans
• Monitors for drug side effects of RAPT compounds in relationship to human exposure
• Analyzes and documents PK reports related to RAPT clinical studies focused on safety and efficacy
• Interfaces with clinical development lead(s) for functional strategy
• Interfaces with Biostatistics and/or clinical development lead for study design/development
• Strategizes and articulates dose justification for RAPT compounds
• Coordinates with key vendors to execute modeling analyses
• Develops timely and forward-looking phase-specific biopharmaceutic studies and analyses
• Develops specific pharmacology and biopharmaceutics sections of regulatory submissions from IND to NDA
• Implements FDA, EMA, ICH guidance to understand ADME properties and phase specific testing and analysis of RAPT compounds in humans with an emphasis on the advisement of necessary studies, development of such studies, and executional oversight
• Provides expertise to prepare the team for key milestone regulatory meetings (eg, EOP2, Scientific Advice)

Qualifications

• Education: PhD with 10 years of experience in a relevant field (e.g. pharmaceutics, PK, PBPK, PK-PD, Pharmacometrics or Systems Pharmacology)
• Experience: 10 years in drug development with direct experience in drug development of investigational large molecule therapeutics; small molecule oral therapeutic experience a plus
• Experience: Translational development experience through all phases including global regulatory submissions; integrates knowledge from Discovery through Phase 4 and supports late-stage placebo-controlled studies in immunology/inflammation or related areas
• Experience: Demonstrated strong leadership competencies in Clinical Pharmacology, PK/PD, and Pharmacometrics for clinical stage programs
• Other Qualifications: Expertise in ICH guidance related to characterizing ADME properties of new drugs
• Other Qualifications: Direct pharmacometrics experience including developing PB-PK and PK/PD models
• Other Qualifications: Experience interacting with regulatory agencies

Skills

• Leadership: clear articulation of strategy and ability to contextualize open questions
• Communication: excellent interpersonal, written, and verbal skills; ability to convey complex technical information clearly
• Collaboration: experience across development phases and managing relationships with contract vendors
• Strategic thinking: ability to present to and influence senior leaders

Education

• PhD in a relevant field (e.g., pharmaceutics, PK, PBPK, PK-PD, Pharmacometrics, Systems Pharmacology) with at least 10 years of related experience