Study Director

About the Company

Join a leading bioanalytical laboratory and help advance pharmaceutical and biopharmaceutical research using state-of-the-art facilities while ensuring compliance with global regulatory standards. Multiple openings across their LCMS / Immunoassay / Cell and Molecular teams for those with relevant experience.

About the Role

As a Study Director, you will spearhead bioanalytical studies, offering critical scientific and regulatory oversight to drive innovation in drug development.

Responsibilities

• Study Oversight: Manage all aspects of assigned studies, including planning, execution, analysis, and reporting. Serve as the primary sponsor contact and ensure timely delivery of milestones.
• Regulatory Compliance: Uphold GxP, ALCOA++ Data Integrity, and ICH M10 guidelines. Address audit findings and contribute to quality management.
• Project Management: Oversee project budgets, track financial milestones, and manage scope changes efficiently.
• Team Collaboration: Work cross-functionally to ensure effective project execution. Train and mentor team members to meet regulatory standards.
• Safety & Quality: Promote workplace safety and support the development of departmental protocols.

Qualifications

• Degree in a scientific or lab-based field (postgraduate preferred).
• 5+ years of experience in regulated bioanalysis (GLP / GCP), ideally within pharmaceuticals or CROs.
• Proven regulatory experience in roles like Scientist, Study Director, Study Coordinator, or Principal Investigator.
• Hands-on with one or more of the following techniques: LCMS / Flow Cytometry / Immunoassays
• Strong problem-solving, time management, and communication skills.
• Experience with tools such as Microsoft Word/Excel; familiarity with Laboratory Management Systems (e.g., Watson LIMS) is a plus.
• Leadership capabilities and a passion for mentoring colleagues.

Required Skills

• Strong problem-solving, time management, and communication skills.
• Experience with tools such as Microsoft Word/Excel; familiarity with Laboratory Management Systems (e.g., Watson LIMS) is a plus.
• Leadership capabilities and a passion for mentoring colleagues.

Preferred Skills

• Proven regulatory experience in roles like Study Director, Study Coordinator, or Principal Investigator.

Pay range and compensation package

• Competitive salary: 90,000 AU$–120,000 AU$
• Access to cutting-edge bioanalytical technology.
• Opportunities for professional growth and training programs.
• Relocation package and VISA sponsorship for international candidates.
• A supportive, collaborative work environment focused on innovation and safety.

Equal Opportunity Statement

If you're ready to make a meaningful impact in drug development and thrive in a dynamic, regulatory-driven environment, we want to hear from you.

Start your journey with us today!