Associate Director, Biology

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 to communicate 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 of collaborative 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