American Society for Clinical Pharmacology and Therapeutics (ASCPT)

Director/Sr. Director, Clinical Pharmacology/Biopharmaceutics

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RAPT Therapeutics
South San Francisco, California, United States (hybrid)
29 days ago

Description

PURPOSE OF JOB:          

The Director/Sr. Director of Clinical Pharmacology/Biopharmaceutics will be responsible for overseeing and directing the clinical pharmacology and biopharmaceutics plans, studies, and reports for RAPT clinical development programs, including content for global regulatory submissions such as INDs, CTAs, IBs, NDAs, MAAs, and pediatric plans. This role will report to the Chief Medical Officer and will also serve as a critical interface within the Clinical department and with the research and nonclinical departments.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Leads, integrates, and directs strategy for the clinical pharmacology development activities and communicates strategy to executive management, regulatory agencies, and external peers
  • Leads the strategic planning for drug development activities and projects to define the clinical pharmacology and biopharmaceutics development strategies, goals, objectives, and submission documents
  • Oversees the evaluation of pharmacokinetics/ pharmacodynamics, culminating in translation into informative labeling guidance
  • Leads and executes the strategic integration of modeling and simulation, absorption, distribution, metabolism and pharmacology for drug safety
  • Design and oversee clinical trials focused on understanding the ADME properties of RAPT compounds in humans, including but not limited to special populations, DDI studies, ADME studies, and food effects in partnership with clinical development and clinical operations
  • Monitor for drug side effects of RAPT compounds in relationship to human exposure
  • Analyze and document PK reports related to RAPT clinical studies focused on safety and efficacy
  • Interface with clinical development lead(s) for functional strategy
  • Interface with Biostatistics and/or clinical development lead for study design/development
  • Interface with the Preclinical Toxicology and DMPK groups, to coordinate non-clinical studies to more fully characterize the human ADMET properties of RAPT’s advanced clinical candidates
  • Strategize and articulate dose justification for RAPT compounds

Pharmacometrics

  • Coordinate with key vendors to execute Population PK modeling
  • Lead coordination of PB-PK and PK/PD modeling with external vendors while also interfacing with drug discovery, chemistry, and biomarker scientists to gather needed program insights

Biopharmaceutics

  • Develop timely and forward-looking phase-specific biopharmaceutic studies and analyses
  • Lead biopharmaceutics discussions with all regulatory authorities

Regulatory

  • Develop specific pharmacology and biopharmaceutics sections of regulatory submissions from IND to NDA
  • Understand, educate, and implement 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
  • Provide expertise to prepare the team for key milestone regulatory meetings (eg, EOP2, Scientific Advice)

EDUCATION REQUIREMENTS

  • PhD with 7-10 years of experience in a relevant field (e.g. PK, PBPK, PK-PD, Pharmacometrics or Systems Pharmacology, Drug Metabolism/Transporters)

EXPERIENCE REQUIREMENTS: 

  • 7-10 years in drug development with direct experience in drug development of investigational small molecule oral therapeutics
  • Ideal candidate with experience in multiple therapeutic areas with oncology, inflammation and inflammatory skin diseases is highly preferred.
  • Experience in translational stages of development through all phases of clinical development and global regulatory submissions; Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information
  • Must have demonstrated strong leadership competencies in Pharmacology, PK/PD, Biopharmaceutics, and Pharmacometrics activities from discovery and implementation of timely and phase specific studies and activities through completion across multiple complex projects

LEADERSHIP SKILLS:

  • Clear demonstration of ability to articulate strategy and contextualize open questions
  • Excellent interpersonal skills
  • Advanced knowledge and experience in multiple therapeutic and/or functional areas
  • 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
  • This may be a fully remote position.

OTHER QUALIFICATIONS:  

  • Direct experience overseeing clinical pharmacology studies in humans
  • 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

PAY RANGE INFORMATION:

California law requires pay information in job postings. The specific rate will depend on the successful candidate’s qualifications and prior experience. The annual pay range for this position is $260,500 (entry-level qualifications) to $280,600 (highly experienced).



Requirements

EDUCATION REQUIREMENTS

  • PhD with 7-10 years of experience in a relevant field (e.g. PK, PBPK, PK-PD, Pharmacometrics or Systems Pharmacology, Drug Metabolism/Transporters)

EXPERIENCE REQUIREMENTS: 

  • 7-10 years in drug development with direct experience in drug development of investigational small molecule oral therapeutics
  • Ideal candidate with experience in multiple therapeutic areas with oncology, inflammation and inflammatory skin diseases is highly preferred.
  • Experience in translational stages of development through all phases of clinical development and global regulatory submissions; Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information
  • Must have demonstrated strong leadership competencies in Pharmacology, PK/PD, Biopharmaceutics, and Pharmacometrics activities from discovery and implementation of timely and phase specific studies and activities through completion across multiple complex projects

Job Information

  • Job ID: 67584684
  • Workplace Type: Hybrid
  • Location:
    South San Francisco, California, United States
  • Company Name For Job: RAPT Therapeutics
  • Position Title: Director/Sr. Director, Clinical Pharmacology/Biopharmaceutics
  • Job Function: Other
  • Setting: Biotechnology Company
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Ph.D.
  • Min Experience: 7-10 Years
  • Required Travel: 10-25%
  • Salary: $260,000.00 - $280,600.00 (Yearly Salary)

Please refer to the company's website or job descriptions to learn more about them.

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