American Society for Clinical Pharmacology and Therapeutics (ASCPT)

Clinical-Regulatory Scientific Lead

Spotlight Preferred
Bill & Melinda Gates Foundation
Seattle, Washington, United States
27 days ago

Description

The Design, Analyze, Communicate (DAC) Program is a rapidly growing area of investment run by the BMGF Integrated Development (IDEV) team and is focused on ensuring that BMGF-funded clinical studies and trials are optimized for informative outcomes.

The DAC program provides internal clinical study review services and trial planning grants (TPGs) to the Foundation’s global health Program Strategy Teams (PSTs) and their prospective Principal Investigator (PI) grantees. DAC’s clinical study review services are applied prior to funding decisions or upon request during an ongoing study. DAC’s TPGs help grantees, secure the technical resources they need to plan and execute informative and efficiently designed studies. 

DAC’s review and TPG services ensure that more BMGF studies end with an informative outcome and that more confident decisions can be made in the shortest period of time with the least amount of human and financial resources. This means we get the clear answers we need to help save and improve more lives.

Job Summary

The DAC Clinical-Regulatory Scientific Review Lead (SRL Lead) is the primary clinical trial expert to lead the DAC team’s review of clinical trial protocols, synopses and proposals submitted by PI teams (i.e., prospective BMGF grantees) for funding. In this role, the SRL Lead works across the DAC team of BMGF technical experts and contracted subject matter experts (SMEs) to gain consensus on questions and concerns that are subsequently shared and discussed with PIs as part of the DAC review process.  The Leads also provides thought partnership on behalf of the DAC team to PIs to address the agreed upon questions and concerns resulting from the DAC review.

Core Responsibilities: This is a 50%-time contracted position, with the following responsibilities:

  • Participate, with DAC Program Lead, in initial alignment discussions with PSTs and PI teams regarding the DAC review process.
  • Support DAC Program Lead and, as needed, DAC Sponsor for decision-making needed to manage and prioritize DAC review requests.
  • Lead the overall DAC review and recommendations process: work with DAC Program Lead and Manager to ensure DAC’s review service runs according to schedule.
  • Serve as the clinical-regulatory expert for all DAC reviews: review and provide written comments on review documents such as DAC’s clinical study assessment tool questionnaire, full-study protocols, detailed study synopses, grant proposals and affiliated programmatic documents.
  • Collaborate with DAC’s Quantitative and PKPD Leads and technical SMEs, to identify top-line review comments and key messages for DAC Opportunities List (Protocol Review) and DAC Points to Consider (Advisory Review) documents.
  • Guide DAC medical writer to assemble draft and final review documents: DAC Opportunities List (Protocol Review) and DAC Points to Consider (Advisory Review).
  • Lead the technical discussion of DAC’s Points to Consider (Advisory Review) and Opportunities List (Protocol Review) with DAC Board and SMEs, PST and PI teams (i.e., three separate one-hour calls plus preparation time).
  • Participate in After Action Reviews to provide feedback on the DAC review process (upon request).
  • Serve as DAC Board member; participate in weekly calls.


Requirements

Experience and skills:

  • Advanced medical/biomedical degree (MD, PhD) with 20 years of experience in the conduct, design, implementation, and oversight of clinical trials. Experience in regulatory affairs reviews of medical therapeutics and ideally devices. (note: we are likely to need more than 1 SRL so lack of experience in one area would not be considered a disqualification).
  • Senior leadership experience to effectively manage a group of subject matter experts towards consensus decisions related to clinical trial protocols.
  • Strong decision-making skills and ability to work cooperatively and diplomatically across BMGF internal and external groups (i.e. PI team grantees and DAC SME contractors).
  • Ability to organize and deliver feedback (recommendations) in a way that increases likelihood of feedback uptake while maintaining or enhancing relationships with DAC, PST, and PI team members.
  • Ability to facilitate conversations in a way that enables collaboration and achieves desired outcomes while meeting time constraints.
  • Ability to mentor study teams who enjoy less clinical development experience and less access to resources.
  • Ability to adapt to varied review outcomes and requirements based on customer needs.
  • Ability to adapt to changes in processes, practices, and team members as DAC program grows.
  • Ability to explain and advocate for DAC position (recommendation) while acknowledging the choice to change the study resides with the PI team.

“Nice to have” Additional Experience:

  • Experience facilitating reviews of programs, platforms, and protocols in varying stages of development
  • Experience across a variety of disease areas and study types (e.g., clinical, operational research, etc.)
  • Experience working in low-resourced countries or with study teams based on same
  • Experience working with WHO or LMIC regulatory agencies

Job Information

  • Job ID: 58468242
  • Location:
    Seattle, Washington, United States
  • Position Title: Clinical-Regulatory Scientific Lead
  • Company Name: Bill & Melinda Gates Foundation
  • Job Function: Research and Development
  • Setting: Other
  • Job Type: Contract
  • Job Duration: Indefinite
  • Min Education: Master's Degree
  • Min Experience: Over 10 Years
  • Required Travel: 0-10%

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