Senior Companion Diagnostics Expert

Proclinical is currently recruiting for a Senior Companion Diagnostics Expert with a global pharmaceutical company located in Gaithersburg, MD; Waltham, MA; Cambridge, UK; Gothenburg, Sweden; Shanghai, China. As the Senior Companion Diagnostics Expert, you will play a pivotal role in providing medicines that make a real difference to patient care.

Job Responsibilities:

• Implement 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 investment to enable companion diagnostic development for the relevant product teams
• Deliver expert advice of high scientific quality on strategic direction for precision medicine approaches and companion diagnostic development to relevant product teams
• Provide leadership within PMG, including communication of a clear and inspirational vision.
• As project manager of diagnostic delivery, 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 for 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 companion diagnostic plans to time, budget and quality.
• Track and monitor detailed progress against project delivery
• Assessing and Managing Risk
• Provide regular updates on all PMG activities for the relevant product teams for progress, risks, issues and opportunities to governance bodies or CDU/PMU Head as required
• Work with functional representatives to resolve resource, quality and budget issues
• 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

Skills and Requirements:

• PhD or equivalent experience in a relevant subject
• Experience in of companion diagnostic tests or segmentation tools in clinical development
• Experience of precision medicine approaches and diagnostic development within the relevant therapeutic area
• Evidence of effective skills in communication, stakeholder influencing, programme management
• Significant understanding of the functions involved in companion diagnostic development and how they contribute to achieving the objectives of the business
• High quality scientific expertise in the precision medicine field relevant and therapeutic area as evidenced by publications

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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