Director, Clinical Pharmacology

RAPT Therapeutics, Inc.•South San Francisco, CA

72d•$250,300 - $267,100

About The Position

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.

Requirements

PhD. with 10 years of experience in a relevant field (e.g. pharmaceutics, PK, PBPK, PK-PD, Pharmacometrics or Systems Pharmacology
10 years in drug development with direct experience in drug development of investigational large molecule therapeutics; small molecule oral therapeutic experience a plus
Experience in translational stages of development through all phases of clinical development including global regulatory submissions. Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information; ideal candidate with experience supporting late-stage placebo-controlled studies in immunology and inflammation or related areas
Must have demonstrated strong leadership competencies in Clinical Pharmacology, PK/PD, and Pharmacometrics activities for clinical stage programs
Expertise in ICH guidance related to characterizing the ADME properties of new drugs
Direct pharmacometrics experience including but not limited to developing PB-PK models, PK/PD models
Experience interacting with regulatory agencies
Clear demonstration of ability to articulate strategy and contextualize open questions
Excellent interpersonal skills
Experience across range of development phases
Maintaining and establishing relationships and agreements with contract vendors
Excellent written and oral communication skills and ability to convey complex technical information clearly
Confidence and ability to present to and influence senior leaders

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)