Senior Director Biomarker Operations

Proclinical are collaborating with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis and is located in Germany. The opening position that is currently available in this organisation is for a Senior Director whose main focus will be on Biomarker Operations.

Responsibilities:

• You will adhere to regulations, SOPs, practices, and technical and industry standards throughout all aspects of work.
• Direct and collaborate with those in cross-functional working groups.
• Assist the examination of resources required for upcoming trials and projects.
• Form and uphold effective biomarker sample logistics, such as set-up, tracking, analysis, etc, until data distribution.
• The ideal candidate will assist with developing and evaluating standard procedures and templates.
• Guide biomarker operations owned system executions, meetings and initiatives and represent biomarker operations on pertinent QSM and any other systems initiatives, both internally and externally.
• Responsible for driving development and execution of new strategies and processes linked to biomarker operations to guarantee work is compliant and of high quality.
• Contribute to the pertinent divisional actions such as due diligence actions, forums/workshops, guide/partake in sessions for sharing knowledge, etc.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to an advanced degree level in a biology, pharmaceutical or any other scientific field.
• Familiarity within tactical set-up of central lab operations, study start up, clinical sample tracking/reconciliation and analysis.
• Acquaintance with GCP settings and lab management systems such as LIMS, as well as expertise in therapeutic areas such as oncology, immuno-oncology, or infectious diseases.
• Demonstrable experience in management of direct reports.
• A background in participating in a tactical transformation of operations within a CRO, biotech/pharmaceutical organisation and/or central labs.
• Project management skills.
• Leadership capabilities with the capacity to influence others and resolve issues.
• Demonstrable experience within a pharmaceutical/CRO handling multifaceted biomarker operations and team.
• Communication skills both verbally and in writing.
• Prior involvement in both developing and executing agile, creative solutions.
• Able to work with a sense of urgency.
• Capable of managing various tasks simultaneously as well as meet deadlines.
• Familiarity within a matric organisation working in global teams.
• Works well independently with the ability to manage own time and work well under pressure.
• Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact James Hume @ j.hume@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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