ADME is crucial to further understanding the mechanism of action of a drug and if it will be safe for human consumption. My client, a R&D provider for the pharmaceutical industry, are looking for the expertise of an experienced ADME Study Director to manage operations within their Bioanalysis department at one of their sites in Northamptonshire.
ADME Study Director Key Responsibilities:
- Conduct and direct metabolism studies for new product development based on global regulatory requirements.
- Act as ADME Study Director, Bioanalytical Project Manager and/or Principal Investigator on metabolism studies.
- Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
- Plan work to ensure revenue recognition milestones on assigned studies are hit, flagging up any issues early. Ensure resource allocated to their studies is effectively utilised.
- Calculate and QC check data, reviewing data obtained and preparing study updates as well as study data for discussion internally and for communication to the client/inclusion into reports.
- Address findings arising from QA audits and process inspections.
- Effectively coordinate experimental activities and communicate with clients regarding study progress addressing client comments.
- Supervise, mentor and/or train more junior members of staff.
- Review cost builds for assigned studies with Team Leader, track actual vs budgeted hours providing feedback where changes to cost builds are necessary. Ensure any potential work scope changes are flagged to management.
- Increase profile of the department externally by publishing papers/posters and participation in expert groups.
- Comply with Good Laboratory Practice, Good Clinical Practice and/ or Good Manufacturing Practice requirements whenever appropriate to the work being undertaken.
- PhD in a Life Science subject with previous experience conducting ADME studies in a GLP regulated environment.
- Prior experience operating HPLC and LC-MS techniques.
- Experience of dose formulation and determining formulation stability
- Strong leadership skills, with the ability to adhere to strict deadlines and lead a small team.
- Excellent communication skills, able to hold structured conversations with large pharmaceutical clients.
- Advanced innovation and problem solving skills.