Principal Scientist - Clinical Diagnostics

Placements24; Durban; Hybrid; ZAR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Private healthcare

Life insurance

Retirement fund

Relocation support

Hybrid work options

Professional development

Job summary

Placements24 in Durban, a leader in diagnostic innovation, seeks a Principal Scientist to head Clinical Diagnostics. You will lead assay development, oversee regulatory submissions, and mentor R&D staff in a fast-paced, quality-driven environment.

The role requires a PhD and 8+ years in diagnostic assay development with expertise in PCR, ELISA, NGS, and regulatory pathways such as IVDR and FDA. You will collaborate across departments to translate research into validated products and contribute

Qualifications

• Ph.D. in Biochemistry, Molecular Biology, Immunology, or related field.
• Minimum of 8 years of diagnostic assay development experience in biotech/pharma.
• Proven track record of bringing diagnostic products through regulatory approval.
• Strong understanding of clinical trial design and statistical analysis.

Responsibilities

• Lead R&D in development of new diagnostic assays, including molecular and immunoassay platforms.
• Oversee experimental design, execution, and data analysis for validation studies.
• Ensure compliance with ISO 13485, IVDR, and other regulatory guidelines.
• Manage and mentor a team of R&D scientists and lab personnel.
• Collaborate with clinical affairs, manufacturing, and quality assurance departments.
• Contribute to IP strategy and patent filings.
• Present research findings to senior management and external stakeholders.
• Evaluate and implement new technologies to enhance diagnostics.

Skills

Molecular diagnostics

PCR

ELISA

Data analysis

Regulatory knowledge

Education

PhD in Biochemistry/Molecular Biology/Immunology

Tools

PCR

ELISA

NGS

Microarrays

Job description

About the Role Our client, a prominent leader in diagnostic innovation, headquartered in the coastal city of Durban , is seeking a highly accomplished Principal Scientist to lead their Clinical Diagnostics division. This senior position is central to the development and validation of novel diagnostic assays and technologies for critical diseases. You will guide a team of scientists and technicians, oversee project lifecycles from concept to regulatory submission, and ensure the highest standards of scientific rigor and quality. The ideal candidate will have a deep understanding of molecular diagnostics, assay development, and regulatory pathways (e.g., IVDR, FDA). This is an exciting opportunity to shape the future of medical diagnostics and contribute to improved patient outcomes. The work environment is dynamic, research-intensive, and committed to excellence in healthcare.

Key Responsibilities

• Lead the research and development of new diagnostic assays, including molecular and immunoassay platforms.
• Oversee the experimental design, execution, and data analysis for assay validation studies.
• Ensure compliance with relevant regulatory guidelines (e.g., ISO 13485, IVDR).
• Manage and mentor a team of R&D scientists and laboratory personnel.
• Collaborate with clinical affairs, manufacturing, and quality assurance departments.
• Contribute to the intellectual property strategy and patent filings.
• Present research findings and project updates to senior management and external stakeholders.
• Evaluate and implement new technologies to enhance diagnostic capabilities.

Requirements

• Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related field.
• Minimum of 8 years of experience in diagnostic assay development within the biotechnology or pharmaceutical industry.
• Extensive experience with various assay technologies (e.g., PCR, ELISA, next-generation sequencing, microarrays).
• Proven track record of successfully bringing diagnostic products through regulatory approval.
• Strong understanding of clinical trial design and statistical analysis.
• Experience in team leadership and project management.
• Excellent written and verbal communication skills, with strong presentation abilities.
• Knowledge of quality management systems and regulatory affairs.

Benefits

• Our client offers a highly competitive salary, an annual performance bonus, and a comprehensive benefits package including private healthcare, life insurance, and a generous retirement fund. Opportunities for professional development, continuous learning, and attending scientific conferences are abundant. The role offers a flexible working arrangement with hybrid options, allowing for a healthy work-life balance in the beautiful city of Durban . Relocation support is available for qualified candidates moving to KwaZulu-Natal .