Study Director - Immunoassays

Planet Pharma; Adelaide; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Relocation assistance

Visa support

Job summary

Planet Pharma seeks an experienced Senior Study Director - Immunoassay to lead regulated bioanalytical studies in a high-performance laboratory. You will oversee immunoassay validation and sample analysis programs while providing scientific leadership, project oversight, and mentorship to support teams.

You will be the primary scientific and operational lead for assigned studies, ensuring high-quality data, client satisfaction, and successful project outcomes.

Qualifications

• Bachelor's degree or higher in Life Sciences, Biotechnology, Immunology, Pharmacology, Biochemistry, or related discipline.
• 8+ years of experience within regulated bioanalysis, preferably in CRO/pharma
• Demonstrated experience leading regulated studies as a Study Director or equivalent
• Strong GLP and regulatory requirements knowledge
• Extensive experience with immunoassay validation and sample analysis
• Proven ability to manage multiple projects with demanding timelines
• Strong client-facing communication and stakeholder management
• Experience with assay development, transfer, and validation activities
• Experience supporting regulatory inspections and client audits
• Financial, budgeting, or operational planning experience

Responsibilities

• Serve as Study Director, Principal Investigator, or equivalent scientific lead for regulated bioanalytical studies.
• Take overall responsibility for planning, execution, reporting, and delivery of assigned projects.
• Manage multiple studies simultaneously, ensuring milestones and client expectations are met.
• Develop and maintain project timelines and proactively manage study risks and challenges.
• Ensure studies are conducted in accordance with applicable regulatory requirements, quality standards, and client protocols.
• Coordinate study activities across laboratory operations, scientific teams, quality functions, and project stakeholders.
• Act as the primary scientific contact for clients, providing project updates and scientific guidance.
• Build strong relationships with sponsors, CRO partners, and external stakeholders.
• Review, interpret, and communicate scientific data and study outcomes.
• Lead investigation and resolution of technical or scientific challenges arising during study conduct.
• Collaborate with assay development teams to support transfer of methods into validation and routine analysis.
• Provide leadership, coaching, and technical guidance to Study Coordinators, Project Support staff, and junior scientists.
• Assist with onboarding, training, and development of team members.
• Foster a collaborative, quality-focused, and high-performance culture.
• Support workload planning and resource allocation across assigned projects.
• Work closely with operational teams to ensure studies progress efficiently through laboratory workflows.
• Contribute to departmental objectives, including utilisation, productivity, quality metrics, and financial performance.
• Support client management activities and contribute to business growth opportunities where appropriate.
• Assist in forecasting project requirements and resource needs.
• Maintain scientific integrity and regulatory compliance across all assigned studies.
• Ensure adherence to GLP, GCLP, GMP, and other regulatory standards.
• Participate in audits, inspections, and compliance initiatives as required.
• Contribute to SOPs, processes, and quality systems development and improvement.
• Stay informed of evolving industry trends and regulatory expectations.
• Act as delegate for senior scientific leadership when required.
• Support cross-functional initiatives and continuous improvement projects.
• Contribute to organisational goals and promote a culture of quality and accountability.
• Comply with health, safety, and workplace policies.

Skills

Study leadership

Regulatory knowledge

Immunoassay

Project management

Client communication

Education

Bachelor's degree or higher in Life Sciences or related

Tools

LIMS platforms

Electronic laboratory systems

Job description

We are seeking an experienced Senior Study Director - Immunoassay to lead regulated bioanalytical studies within a high-performing laboratory environment. This position is responsible for overseeing immunoassay-based method validation and sample analysis programs while providing scientific leadership, project oversight, and mentorship to support teams.

The successful candidate will serve as the primary scientific and operational lead for assigned studies, ensuring delivery of high-quality data, regulatory compliance, client satisfaction, and successful project outcomes.

KEY RESPONSIBILITIES

• Serve as Study Director, Principal Investigator, or equivalent scientific lead for regulated bioanalytical studies.
• Take overall responsibility for the planning, execution, reporting, and delivery of assigned projects.
• Manage multiple studies simultaneously, ensuring milestones and client expectations are met.
• Develop and maintain project timelines and proactively manage study risks and challenges.
• Ensure studies are conducted in accordance with applicable regulatory requirements, quality standards, and client protocols.
• Coordinate study activities across laboratory operations, scientific teams, quality functions, and project stakeholders.

Scientific & Client Management

• Act as the primary scientific contact for clients, providing project updates and scientific guidance.
• Build strong relationships with sponsors, CRO partners, and external stakeholders.
• Review, interpret, and communicate scientific data and study outcomes.
• Lead investigation and resolution of technical or scientific challenges arising during study conduct.
• Collaborate with assay development teams to support transfer of methods into validation and routine analysis.
• Provide leadership, coaching, and technical guidance to Study Coordinators, Project Support staff, and junior scientists.
• Assist with onboarding, training, and development of team members.
• Foster a collaborative, quality-focused, and high-performance culture.
• Support workload planning and resource allocation across assigned projects.

Operational & Business Support

• Work closely with operational teams to ensure studies progress efficiently through laboratory workflows.
• Contribute to departmental objectives, including utilisation, productivity, quality metrics, and financial performance.
• Support client management activities and contribute to business growth opportunities where appropriate.
• Assist in forecasting project requirements and resource needs.

Quality & Compliance Responsibilities

• Maintain scientific integrity and regulatory compliance across all assigned studies.
• Ensure adherence to GLP, GCLP, GMP, and other applicable regulatory standards.
• Participate in audits, inspections, and compliance initiatives as required.
• Contribute to the development, review, and continuous improvement of SOPs, processes, and quality systems.
• Stay informed of evolving industry trends, guidance documents, and regulatory expectations.

Additional Responsibilities

• Act as delegate for senior scientific leadership when required.
• Support cross-functional initiatives and continuous improvement projects.
• Contribute to organisational goals and promote a culture of quality, accountability, and excellence.
• Comply with all health, safety, and workplace policies.

QUALIFCATIONS & EXPERIENCE

• Bachelor's degree or higher in Life Sciences, Biotechnology, Immunology, Pharmacology, Biochemistry, or a related discipline.
• 8+ years of experience within regulated bioanalysis, preferably within a CRO, pharmaceutical, biotechnology, or laboratory services environment.
• Demonstrated experience leading regulated studies as a Study Director, Principal Investigator, or equivalent scientific lead.
• Strong understanding of GLP and bioanalytical regulatory requirements.
• Extensive experience with immunoassay validation and sample analysis.
• Proven ability to manage multiple projects simultaneously while meeting demanding timelines.
• Strong client-facing communication and stakeholder management skills.
• Excellent scientific troubleshooting and data interpretation abilities.
• Previous experience leading, mentoring, or managing scientific teams.
• Experience with LIMS platforms and electronic laboratory systems.
• Exposure to assay development, transfer, and validation activities.
• Experience supporting regulatory inspections and client audits.
• Financial, budgeting, or operational planning experience.

LOCATION

Adelaide, Australia - full relocation and visa support can be offered.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.