Reports to: Vice President, Technical Operations
Job Code: 2018-70-15
The Manager, ADMET Programs will be responsible for the design and implementation of formal (e.g., GLP) nonclinical studies and ADME studies to be conducted by contract research organizations (CROs) and will oversee external collaborations with CROs and other organizations/consultants. S/he works strategically and tactically, selecting and integrating Contract Research Organization (CRO) activities into internal program plans and assuring regulatory and quality expectations are met. This individual works under general direction.
- Develops and implements ADMET strategies generating data to support development candidate IND-enabling studies. Contributes to clinical pharmacology strategy and planning for clinical programs through internal project teams and external consultants
- Provides scientific expertise for the design, analysis, reporting and presentation of data from nonclinical studies conducted to support clinical programs and regulatory filings. Solicits scientific input, both internally and via outside experts
- Ensures that non-clinical studies are effectively conducted to support IND submissions, including ADME, PK, safety pharmacology, and GLP toxicology
- Prepares and/or reviews nonclinical sections of all regulatory submissions for assigned development projects and interacts with regulatory agencies, as needed
- Participates in vendor selection and qualification; developing scope of work, plans and reviews technical content, leads technical and data-based decision making, negotiating plans and holding vendors accountable for deliverables
- Manages protocol and report review, including coordination and execution of protocol and report review meetings
- Reviews and QC’s nonclinical toxicology, ADME and DMPK reports
- Coordinates PK/PD modeling to support dosing strategies for clinical programs
- Ensures appropriate quality of documentation as well as timely and accurate communication of study results and interpretation to appropriate internal drug development teams
- Complies with all applicable policies regarding health, safety and environmental policies
- PhD with a minimum of 8 years in a relevant field, with accomplished experience in pharmacology, drug metabolism, clinical pharmacology and/or toxicology or equivalent within drug discovery and/or development processes within the biotechnology or pharmaceutical industry.
- Experience with in vitro/in vivo studies to determine the effects of therapeutics on ADMET in the context of drug development in humans
- Significant experience working with ADMET vendors through the various stages of drug development
- Ability to identify and resolve complex development challenges, including data analysis and data management
- Excellent verbal, written and presentation communication skills required. Must have strong interpersonal skills with the ability to work collaboratively with team members or independently
- Experience writing nonclinical toxicology and/or Clinical Pharmacology sections of regulatory submission documents. Demonstrated knowledge of GLP, GCP, and ICH guidelines
- Strong productivity/organizing/planning skills with the ability to manage projects and meet deadlines. Demonstrates effective use of time and handles multiple projects simultaneously
- Demonstrates a sense of urgency, proactive thinking, and productivity in a fast-paced, innovative and team-oriented environment.
- Ability to travel approximately 20% [domestic and international]
GlycoMimetics, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter to HR@glycomimetics.com and reference job number 2018-70-15 in the subject line.