Senior Scientist - Clinical Diagnostics Development

Placements24; Kimberley; Hybrid; CAD 110,000 - 160,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive salary + bonuses

Health, dental, vision insurance

Professional development

Impact on patient outcomes

Job summary

Placements24 in Kimberley is seeking a Senior Scientist to lead clinical diagnostics development, including design, validation, and implementation of novel assays. This hybrid role blends on-site strategy with remote collaboration to drive innovation and patient impact.

The ideal candidate will hold a PhD or MSc in a related field, with 5+ years in diagnostic development, strong regulatory know-how, and demonstrated leadership across cross-functional teams.

Qualifications

• Requires 5+ years in clinical diagnostics development, including assay design and validation.
• PhD or MSc in a relevant life science field is required.
• Deep knowledge of regulatory requirements for medical devices & diagnostics (FDA/ISO 13485).

Responsibilities

• Lead development and validation of new clinical diagnostic assays with robust, reproducible results.
• Oversee all phases from concept to regulatory submission for assays.
• Establish and maintain QC procedures to ensure accuracy of diagnostics tests.
• Collaborate with clinical teams, R&D, and regulatory affairs to meet milestones.
• Analyze complex data to drive decisions and guide project direction.
• Mentor junior scientists and provide technical leadership within the team.

Skills

5+ years of experience in clinical_d*/

Assay design & validation

Regulatory knowledge (FDA/ISO13485)

Education

PhD or MSc in Clinical Laboratory Science / Biochemistry / Molecular Biology

Tools

PCR

Immunoassay

NGS

Job description

About the Role

Our client is seeking a highly experienced Senior Scientist to lead critical projects in Clinical Diagnostics Development. This hybrid role based in Kimberley offers a significant opportunity to contribute to the advancement of diagnostic technologies that impact patient care. You will be responsible for overseeing the design, development, validation, and implementation of novel clinical assays. This position requires a strong background in assay development, a thorough understanding of regulatory requirements, and excellent project management skills. You will work within a collaborative team environment, balancing on-site strategic work with remote flexibility to ensure project success and innovation.

Key Responsibilities

• Lead the development and validation of new clinical diagnostic assays, ensuring robustness and reproducibility.
• Oversee all phases of the assay development lifecycle, from concept to regulatory submission.
• Establish and maintain quality control procedures to ensure the accuracy and reliability of diagnostic tests.
• Collaborate with clinical teams, R&D scientists, and regulatory affairs to meet project milestones.
• Analyze and interpret complex experimental and clinical data to drive decision-making.
• Mentor junior scientists and provide technical expertise within the development team.

Requirements

• PhD or Master's degree in Clinical Laboratory Science, Biochemistry, Molecular Biology, or a related field.
• Minimum of 5 years of experience in clinical diagnostics development, including assay design and validation.
• Proven experience with various diagnostic platforms and technologies (e.g., PCR, immunoassay, NGS).
• In-depth knowledge of regulatory requirements for medical devices and diagnostics (e.g., FDA, ISO 13485).
• Strong analytical and problem-solving skills.
• Excellent communication and leadership abilities for a hybrid work setting.

Benefits

• Competitive salary and annual performance bonuses.
• Hybrid work arrangement offering flexibility and work-life balance.
• Comprehensive health, dental, and vision insurance plans.
• Support for continuous professional development and advanced training.
• Opportunity to shape the future of clinical diagnostics and patient outcomes.