Companion Diagnostics Director

Proclinical is currently recruiting for a Companion Diagnostics Director with a global pharmaceutical company located in Gaithersburg, MD; Waltham, MA; Cambridge, UK; Gothenburg, Sweden; Shanghai, China. As the Companion Diagnostics Director, you will be accountable for ensuring that diagnostic tests or equivalent segmentation tools are delivered to drug products within their therapeutic area of expertise.

Job Responsibilities:

• Ensure the adoption of appropriate diagnostic development strategies within the product teams to meet the needs of patients, payers, physicians and add value to drug products
• Obtain and manage strategic investment to enable diagnostic development for the product teams
• Deliver expert advice of high scientific quality on strategic direction for precision medicine approaches and diagnostic development to relevant product teams
• Provide leadership for the Diagnostic Development sub-team, including communication of a clear and inspirational strategic vision.
• Contribute to the performance management and personal development of project team members
• Monitor and ensure compliance with all company Policies and Standards and immediately address instances of non-compliance
• Create and implement delivery of diagnostic tests for use in clinical trials, regulatory submission and commercialization
• Draw upon previous experience and expert knowledge to provide a relevant knowledge base of companion diagnostic development and competitive intelligence to product teams
• Ensure delivery of objectives, project plans, financial investments and milestones for companion diagnostic delivery to product teams with the Heads of CDU/PMU and relevant product leaders
• Accountable for the delivery of diagnostic plans to time, budget and quality
• Provide regular updates on all PMG activities to the relevant product teams for progress, risks, issues and opportunities to governance bodies for review, challenge and issue resolution
• Work with functional representatives to resolve resource, quality and budget issues
• Ensure that members of Diagnostic Development sub-team manage risk in an appropriate and compliant manner
• Governance processes and stakeholder interactions
• Provide metrics to senior leaders and to governance bodies (e.g. Early Stage Product Committee (ESPC) or Late Stage Product Committee (LSPC)) as required
• Ensure that all governance issues are identified and reported appropriately

Skills and Requirements:

• PhD or equivalent experience in a relevant subject
• Experience in diagnostic tests or segmentation tools in clinical development, within a diagnostic or pharmaceutical setting
• Significant experience of Precision Medicine approaches and diagnostic development within the relevant therapeutic area
• Evidence of excellent skills in communication, stakeholder influencing, programme management, and regulatory interactions
• Effective leadership, performance management and talent management
• Comprehensive understanding of the functions involved in companion diagnostic development and how they contribute to achieving the objectives of the business
• Significant previous experience in similar role in different companies
• Delivery of diagnostics, regulatory interactions and commercialisation
• High quality scientific expertise in the precision medicine ield relevant and therapeutic area as evidenced by publications and external reputation
• Evidence of external interactions in the diagnostic field e.g. diagnostic partnering, regulation of drugs and linked diagnostics, payer and policy considerations, ethical and legal aspects
• Effective leadership of global teams

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@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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