- Merck & Co. (Boston, MA)
- …direction of companion diagnostics (CDx). - Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with ... Job DescriptionThe Associate Vice President (AVP) / Companion Diagnostics will be responsible for leading the diagnostics strategy, bridging the continuum… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's ... to the FDA and other health authorities globally.At least 4 years of companion diagnostic development experience within a pharmaceutical company.At least 2 years… more
- Merck & Co. (Boston, MA)
- …leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/ companion diagnostics (CDx), including associated ... field and five (5) years of experience in industry (pharmaceutical or companion diagnostics )Required Experience and Skills:Extensive experience with one or more… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key scientific questions and steps taken to answer them.- With the Companion Diagnostics group, develop a companion diagnostic plan for the program ... In addition, he or she will interact with counterparts in the Companion Diagnostics group to support the program. Other responsibilities will include but not… more
- Merck & Co. (Boston, MA)
- …to drive Precision Medicine visionSupport the development, approval and commercialization of diagnostics developed as companion or complementaryServe as the key ... experimental medicine leader in our newly created Precision Medicine and Diagnostics function. Reporting to the Associate Vice President ,Precision Medicine and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agreements (among other types of agreements) in the pharmaceutical and companion diagnostic fields, including drafting, negotiating and reviewing such ... and reviewing licensing, co-promotion, co-development, co-marketing, clinical trial collaboration, companion diagnostic , and acquisition agreements.- Conducts patent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the continuum of preclinical and clinical stages preferred.- Experience/knowledge in companion diagnostics device development preferred- Demonstrated ability to ... define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development required- Deep knowledge in pathology-based and other biomarker technologies including immunohistochemistry (monoplex and… more
- Genmab (NJ)
- …trial designsExperience with drug development in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA, EMA, and ICH ... guidance for drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such… more
- Danaher Corporation (Deer Park, IL)
- …is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology ... matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers and aid...working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further regions are… more
- Merck (Washington, DC)
- …scientific direction of companion diagnostics (CDx). Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with ... **Job Description** The Associate Vice President (AVP) / Companion Diagnostics will be responsible for...to stay up to date regarding industry trends and diagnostic regulatory requirements. **Essential Job Requirements:** + Develop end-to-end… more
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