Description

Position Overview

The Director/Senior Director, Head of Bioanalysis is primarily responsible for providing bioanalytical leadership in support of Disc Medicine’s drug development and clinical programs. The incumbent will be responsible for leading/managing bioanalytical studies (both GLP and non-GLP) outsourced to CROs. The incumbent should have demonstrated expertise and leadership skills in bioanalytical field, working experience in industry in both non-GLP and GLP environment, and familiar with bioanalytical related regulatory guidance.  Excellent communication and CRO management skills are required to interface with the discovery, nonclinical, and clinical teams to support preclinical and clinical programs. 

Requirements

Responsibilities include, but are not limited to, the following:

Leading the overall scientific, technical and operational efforts of the Bioanalytical activities in support of preclinical and clinical programs

Directs internal and external bioanalytical activities, including routine studies, troubleshooting, and issue management

Provides scientific excellence by setting the standard for quality bioanalytical research within Disc.  Manage internal project support and be responsible quality, quantity and timelines of Bioanalysis for program teams

Facilitate communications across all functional areas; establishes effective partnerships/relationships internally and externally

Requirements

- PhD in analytical chemistry, bioanalytical chemistry, Pharmaceutical Sciences, biology, immunology or    

  a related field.
- 8+ years’ experience of Bioanalysis in the pharmaceutical industry

- Demonstrated expertise in bioanalysis for antibody and anti-drug antibody assays

- Expertise in bioanalysis for biomarkers and/or pharmacodynamic markers is required

- Expertise in bioanalysis using LCMS and other bioanalytical tools is a plus

- Working experience in GLP environment in supporting toxicology and clinical studies, familiar with 

  regulatory guidance in bioanalytical field
- Scientific knowledge of Drug Discovery, Development, and DMPK/ADME areas

- Excellent leadership, managerial and problem-solving skills.

- Excellent written and communication skills
- Excellent CRO management skills and willingness to be hands-on