Study Director - LCMS
Location Adelaide, Australia
Study Director – LCMS
An exciting opportunity for an experienced Study Director to join a Regulated Bioanalytical laboratory which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry. This role is based in Adelaide, Southern Australia, and a comprehensive relocation package is on offer.
The Study Director – LCMS will be responsible for performing Study Director functions for mass spectrometry-based validations and analysis. Reporting to the Senior Study Manager, the main responsibilities of role include:
- Manage studies to ensure timelines are firstly set appropriately taking into account company and external stakeholder requirements, and once set, ensure timelines are achieved.
- Communicate effectively with external stakeholders (i.e. clients, Clinical Research Organisations (CROs)).
- Communicate with internal stakeholders (i.e. operations, Quality Assurance (QA), management) to ensure project progression.
- Ensure the scientific integrity and regulatory compliance of study data by (at minimum) the review of all runs.
- Troubleshoot scientific issues by liaising with appropriate groups including Research & Development (R&D), operations, management.
- Coordinate with operations and, in particular, the Lead Analyst to ensure operational progression of studies.
- Liaise with R&D to ensure smooth transition of methods into validation.
You will also be responsible for the update and review of Analytical Laboratory Methods (ALM), having an input in Standard Operating Procedures (SOPs) relevant to Study Director role, and being able to be assigned Deputy Study Director duties as required.
Ideally candidates will be degree qualified (or equivalent) in life sciences or related relevant subject. The successful applicant will also have significant industry experience working as a Study Director, and experience in regulated Bioanalysis, ideally in a pharma or CRO environment.
This is a great opportunity to join a growing company, and also to make a dream move to Australia. If it sounds like the opportunity for you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.