Director, Clinical Pharmacology

PURPOSE OF JOB:

TheDirector, 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.

MAJOR DUTIES AND 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

Regulatory

• 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)

EDUCATION REQUIREMENTS:

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

EXPERIENCE REQUIREMENTS:

• 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

OTHER QUALIFICATIONS:

• 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

Leadership Skills

• 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

California law requires pay information in job postings. The specific rate will depend on the successful candidates qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $250,300 (entry-level qualifications) to $267,100 (highly experienced).