General Description:
The primary responsibilities of this position are to develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure that the diagnostic strategy is aligned with the development strategy and with timelines for registration of the pharmaceutical asset.
Key Responsibilities:
- Develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure alignment with clinical development strategies and timelines.
- Interact early with Translational Discovery and Research to understand the predictive hypotheses to be tested for specific programs.
- Collaborate effectively with internal research teams or external vendors to develop a predictive assay if not already available.
- Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies (e.g., DCT, DRC, BPRC etc.).
- Work with a cross-functional team to define Diagnostic Target Product Profile (DxTPP) and identify suitable assays and CDx partners based on DxTPP.
- Work with Regulatory Affairs to ensure that regulatory documents (e.g., IDEs, PMAs, etc.) are delivered and communicate with health authorities when required.
- Participate in regulatory meetings with global HAs including the US and EU
- Oversee the CDx development and ensure timely delivery of a CDx kit for pharmaceutical registration and launch.
- Communicate updates to, and seek feedback from, cross-functional stakeholders surrounding the progress of the CDx program.
- Stay up to date with industry trends, technology advancements, and regulatory requirements for CDx.
- Drive diagnostic product innovation and improvement through both in-house R&D efforts and in collaboration with IVD partners.
- Participate in other training and management activities as required by the company.
Requirements:
- PhD or MD in biology/medical majors.
- 5+ years of industry experience in clinical biomarker testing and CDx development.
- Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for IVD products and CDx.
- Technical expertise in at least one type of diagnostic technology, e.g.: NGS, IHC, proteomics, etc.
- Demonstrated ability to drive projects through to completion on time and within budget.
- Ability to identify key information and make data driven decisions; ability to use critical and strategic thinking to handle complex or ambiguous situations; ability to think at a portfolio level when considering investment decisions.
- Ability to influence stakeholders on development and commercial teams; ability to set and manage stakeholder expectations; ability to influence without authority.
- Ability to articulate facts, ideas, and strategies in all communication formats, particularly to those who do not have medical backgrounds.
- Ability to work effectively in a matrixed environment, ability to manage cross-functional teams.