Molecular Diagnostics Science Manager

hace 3 semanas

Barcelona, España Morgan Philips Executive Search A tiempo completo

As a Molecular Diagnostics Science Manager, you will use your knowledge of DNA/RNA molecular assays (qPCR, dPCR, NGS) to provide scientific, technical and clinical operational expertise to drug project teams following a diagnostics approach.

**The role holder will be accountable for**:
delivery of work packages involving the development of diagnostics as agreed with project leaders

developing innovative diagnostics science across core therapeutic areas

scientific and regulatory aspects of diagnostic test establishment in testing laboratories, including delivery and quality control of clinical data packages to enable regulatory approvals to support market adoption and life cycle management.

ensuring that all activities are delivered supporting policies, standards and procedures, including compliant management of Budget, Safety, Health and Environment.

**Typical Accountabilities, what you will be doing**:
Lead innovative diagnostic science to fulfill Precision Medicine approaches and deliver diagnostic testing to clinical studies as agreed with project leaders including:
Technical and scientific input into the diagnostic strategy

Technical due diligence on diagnostic partner options

Delivery of technical evaluation of assays/test labs

Lead diagnostic test establishment in partner laboratories

QC and Monitor diagnostic test data throughout duration of clinical trial

Provide scientific troubleshooting when necessary

Preparation of study reports with presentation at appropriate meetings.

Lead the delivery of diagnostic data work packages to enable regulatory submission and approval as well as identifying opportunities to remove barriers to real-world diagnostic testing.

Build and maintain a knowledge of current and emerging diagnostic assay technologies in area of expertise.

Drive continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients.

Be accountable for the time, cost and quality of agreed deliverables.

Provide updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution.

Takes on small supervisory or skills transfer / training roles

Monitor and ensure compliance with all Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.

**Education, Qualifications, Skills and Experience**:
**Essential**:
Excellent molecular biology skills including experience in Next-Generation Sequencing (NGS), qPCR and/or dPCR, DNA and RNA handling methods and other relevant molecular biology and/or genomics technique.

Excellent knowledge of scientific literature with deep understanding in molecular biology and/or diagnostic related area demonstrated through publications in peer reviewed journals.

Knowledge of analytical diagnostic assay validation and use in a clinical testing setting.

Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, ISO and Quality Systems Regulation

Knowledge of delivery and use of data for diagnostic development for regulatory submissions, including proven experience of quality control and data monitoring and troubleshooting.

Experience of working with external partners or collaborators (ideally diagnostic companies) to drive timely and successful outcomes, through effectively working across internal and external boundaries.

Ability to communicate with cross-functional stakeholders for project updates through oral presentations and progress reports

Ability to identify risks and escalate appropriately

Ability to work collaboratively within large cross-functional team(s) including multiple internal and external partners

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