The Companion Diagnostics Manager will guide the strategy and implementation of fit-for-purpose companion diagnostics (CDx) in support of specific therapeutic programs of our sponsor. The main focus of the activities is to develop the CDx development strategies for their intended use in alignment with the clinical development plan and to ensure the timely implementation by managing collaborations with diagnostic partners. The Companion Diagnostics Manager co-leads joint cross-functional project teams (JPT) which are the core interface between diagnostic partners and the Pharma organization for any personalized healthcare (PHC) collaboration focused on co-developing companion/complementary diagnostics.
The key responsibilities include:
- Develop and lead the implementation of complex, fit-for-purpose companion diagnostic assay strategies in support of therapeutic programs and ensure alignment of companion diagnostic development milestones with clinical milestones and overall biomarker strategy
- Manage multiple CDx developments and serve as the single point of contact to Diagnostic Partners by providing matrix leadership to cross-functional CDx Joint Project Teams (JPTs) to ensure the execution of CDx strategies and jointly defined deliverables, from assay development kick-off to transition to the late stage development organization.
- Foster cross-functional networks to effectively manage and implement CDx developments. Align closely with the late stage CDx team to ensure smooth transitions into late stage development.
- Provide diagnostic technical expertise and work closely with biomarker leaders, regulatory, statistics, sample operations, and clinical science representatives on the successful and timely implementation of companion diagnostic assays in clinical trials.
- Represent CDx strategies to health agencies as part of the regulatory strategies for the agents within the entire portfolio.
- Develop and lead cross-functional CDx strategic initiatives, including the assessment of new diagnostic technologies.
- University degree in life sciences, PhD.
- > 5 years of relevant experience in industry based drug or diagnostic assay development.
- Broad knowledge and understanding of established and novel diagnostic assay technologies (e.g., IHC, digital pathology, immunoassays, PCR, NGS, liquid biopsy).
- Understanding and experience in the drug development process (clinical trials, efficacy endpoints, biomarker testing).
- Significant understanding and experience with development of diagnostic devices (IVDs) as well as understanding of the operational considerations in executing biomarker and companion diagnostic strategies in clinical development.
- Preferably understanding of the regulatory requirements for approval of a companion diagnostic both from the device and clinical development perspective.
- Excellent planning, project management and organisational skills in order to manage multiple projects and meet assigned deliverables.
- Strategic agility and ability to adapt to the evolving personalized healthcare environment
- Ability to work well on teams and keep relevant stakeholders informed regarding status of programs.
- Strong social and interpersonal skills – able to build and maintain relationships and cross functional networks with key internal and external stakeholders.
- The position is ideally located at the main A4P offices in Sandwich, Kent although working from home with expensed travel to the office weekly / biweekly is open for consideration. The role will also involve some limited European travel, once or twice per quarter.
Further information about the role can be obtained by from Ian James (email@example.com, +44 7798 535050)