Associate Director, Biology

Company Description

Revelation Biosciences, Inc. is a clinical-stage biotech company dedicated to restoring immune balance by targeting inflammation through its proprietary Gemini formulation. The company is advancing a diverse pipeline of programs evaluating Gemini across multiple indications, including the treatment of chronic kidney disease, prevention of post-surgical infections, and management of acute kidney injury.

Position Overview

The company is searching for an experienced Associate Director, Biology who oversees GLP-regulated bioanalytical activities supporting nonclinical and clinical studies. This is a key position responsible for ensuring the design and execution of bioanalytical assays in support of regulatory submissions, including management of GLP-compliant CROs. This role also requires identification and assessment of biomarkers to demonstrate pharmacodynamics of Gemini in a stage-appropriate manner. The ideal candidate will have practical experience in Regulatory requirements and submissions (FDA, EMA), Nonclinical (GLP), Clinical Operations (GCP/ICH), and familiarity with CMC requirements for a small to mid-sized biotechnology company. Effective collaboration with Revelation peers, project teams, and management, is key to success in advancing Gemini to patients.

Responsibilities for the Role

• Direct the daily operations for the development and validation of bioanalytical assays for PK, TK, and PD as well as supporting other new modalities;
  
• Support all biology efforts to provide high quality documentation, including bioanalytical reports to support regulatory submissions within aggressive timelines;
  
• Partner with nonclinical and clinical pharmacology on PK/PD modeling activities;
  
• Work closely with CMC, nonclinical, and clinical teams to support development of therapeutic programs through proof-of-concept and target validation through identification of biomarkers of activity, including outsourcing in vitro assays;
  
• Identify and manage specialized bioanalytical and biology vendors, CROs, and/or collaborators with appropriate expertise;
  
• Work closely with nonclinical, clinical, and regulatory teams to design and execute appropriate bioanalytical assays and effectively present assay results, reports, and recommendations to relevant groups;
  
• Understand preclinical and clinical quality standards to ensure production of data of the highest integrity (e.G. GLP and/or GMP compliance, SEND data requirements);
  
• Contribute relevant bioanalytical sections to regulatory and submission document (e.G. IB, CTD.) as needed;
  
• As required, work with department budgeting and forecasting process to build and maintain the budget.

Required Skills

• 15+ years’ experience in with a small to mid-stage biotechnology company, with 10+ years in regulated Bioanalysis
• 10+ years experience with GLP-compliant bioanalytical CRO management;
  
• Familiarity with nonclinical study design requirements and data interpretation;
  
• Familiarity with clinical pharmacology data requirements and interpretation;
  
• Coordinate and plan project and lab resources to ensure high quality data delivery within timelines in support of corporate goals;
  
• Must be able tocommunicate ideas and information clearly, effectively, and frequently (oral and written) within a team, the company, and with outside consultants;
  
• Proven track record of managing multiple projects simultaneously and meeting deadlines;
  
• General willingness to assist as needed across all departments;
  
• Facilitation ofcollaborative environment.

Education and Experience

• Minimum of bachelor’s degree, preferably in biology or relevant scientific curriculum
• 10+ years in regulated GLP analysis preferred
• Experience supporting regulatory submissions, including review and authorship of relevant sections
• Understanding of GMP, GLP, and GCP-compliant requirements a plus