Companion Diagnostics Director

Highly Competitive Salary
  1. Permanent
  2. Biochemistry, Biological Sciences, Pharmacology
  3. United States
Waltham, USA
Posting date: 10 Dec 2020

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

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.