Director/Sr. Director, Diagnostic Strategy - United States
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- Reporting to the Chief Business and Strategy Officer, the Senior Manager / Head of Non-Invasive Strategy is responsible for developing and leading the Company’s efforts to evaluate the use of non-invasive technologies (serum, imaging, respiratory and others) to risk stratify, diagnose, monitor, prognosticate various non-viral, chronic liver diseases of strategic interest to the firm, with a focus on NASH and cholastatic liver diseases.
- This role would entail developing and implementing a long-term strategy that complements the current approved therapeutic disease area for currently identified and new indications for our products.
- This long term view will need to be created in partnership with specific industry and academic partners globally.
- The position requires extensive interaction and collaborations both within the company and program team and externally with thought leaders and the developers of diagnostic products.
- The position requires appropriate knowledge of a number of fields including liver therapeutics and deep understanding of the biology and potential commercial application of the basic science underlying hepatic injury and its attendant biological response.
- Provide subject matter expertise in non-invasive technology modalities including blood and serum biomarkers, imaging based modalities
- Provide quantitative and qualitative analysis on all relevant non-invasive technologies to relevant program teams (particularly NASH and PBC) and relevant functional departments including strategy, clinical development, commercial, regulatory, business development, and medical affairs
- Enable NASH and cholestatic program teams to incorporate promising technologies as part of ongoing and future clinical development efforts.
- Provide relevant input to support strategic plans and commercial plans, aligning non-invasive technologies with commercial strategy to support NASH market segmentation and corporate positioning
- Lead cross-functional team responsible for the non-invasive strategy for our company’s NASH clinical programs
- Support the selection of and operationalization of non-invasive technologies within our company’s current and future clinical programs in close collaboration with Clinical Development / Operations
- Lead development of algorithms/methodologies for use in ongoing and future clinical trials that would allow for our company’s therapeutic portfolio to be best matched to the patients who are most in need of therapy
- Develop and maintain relationships with both established and emerging non-invasive diagnostic companies worldwide
- Represent our company as an expert in non-invasive diagnostics at both regional, national, and international conferences/meetings
- Enable strategy that is consistent with and adhere to ICH guidelines, Good Clinical Practices, and regulatory requirements