Companion Diagnostic (CDx) Lead
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
- Accountable for successful Companion Diagnostic (CDx) test development and implementation in drug development programs in China to ensure timely submission of Boehringer drug and associated CDx test
- Advise local project teams on patient selection strategies, clinical trial design and identification & application of biomarkers predictive for drug response from a CDx perspective
- Ensure regular Boehringer portfolio oversight regarding CDx needs or opportunities in China
- Collaborate with Boehringer`s Global CDx Center, and across functions (e.g. with Regulatory Affairs, Medicine/ Medical Affairs, Commercial) to ensure specific CDx requirements for China are being heard and considered
- Facilitate (scientific) discussions in the field and work with in-house and field partners to facilitate information sharing and gathering and to optimize communications and coordinated activities
- Be the local primary contact for biomarker related questions in Oncology and act as broker between local and corporate teams
- In close collaboration with Global Experimental Medicine, provide local support where needed for execution of Oncology biomarker strategy in China
- Attend Precision Medicine and CDx webinars, (virtual) meetings/conferences in China, etc. and share the key takeaways from these events with ONCO CDx Development and Boehringer´s CDx Center
- Identify, build relationships (network) and foster interactions with Key Opinion Leaders in China in the Precision Medicine and CDx space (manufactures, regulatory agency, etc.)
- Closely monitor (in collaboration with Regulatory Affairs, China) the policy and evolving regulatory CDx landscape and develop a relationship with NMPA and HGRAC to understand their thinking in the field of Precision Medicine/ CDx, e.g. increased understanding of CDx test reimbursement system in China
- Identify opportunities for collaboration with CROs and Dx companies in China for potential development of local CTA and/or CDx, establish a network for future support (including CDx test developers and providers of clinical NGS testing capability) and provide local ExpMED support for potential site visits/audits and due diligence activities
- Map regional differences in testing capabilities, workflow and platform footprint
Job Requirements
- Medical degree or PhD in Life Sciences, preferably with a focus on Precision Medicine / CDx
- Extensive experience in Precision CDx, and clinical drug development
- Deep understanding of applicable regulatory requirements with focus on China
- Strong disease-area knowledge, particularly in Oncology, with a comprehensive scientific knowledge of the pathophysiology and therapeutic modalities currently approved or in clinical development
- Personal track record in implementing biomarkers / CDx assays in drug development and a clear understanding of the clinical application of such markers, their evaluation and analysis, and the linkage between the biomarker and clinical endpoints
- Excellent communication and negotiation skills with the ability to work effectively in a matrix environment