Principal/Sr Principal Scientist, Hematology Lead Translational Development

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The Principal/Sr Principal Scientist role will be responsible for development and execution of myeloma asset centric translational strategies in hematology for assigned programs. Key responsibilities of this role are to act as a lead scientist to deliver and implement biomarker strategies for clinical programs, develop reports and publications on preclinical and translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to drive execution of translational/biomarker plans working with laboratory and disease scientists and BMS members from clinical, medical, commercial, regulatory and diagnostics as well as engage external academic collaborators/Key opinion leaders (KOLs). This position can be located in Summit, NJ or Princeton/LVL, NJ or Cambridge Crossing, MA

Professional Skills:

• In-depth understanding of cancer biology/hematology with knowledge of current and evolving clinical landscape and competitive scenarios
• Strong scientific background with understanding of clinical, translational, and mechanistic data with proven track record of publications
• Understanding of early or late-stage drug and translational development process; including experience with implementing a biomarker strategy
• Clinical protocol authoring and review of regulatory documents.
• Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry.
• Excellent data analysis and problem solving skills
• Exceptional verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize complex scientific concepts into simple communication points
• Proven scientific/project leadership expertise and experience working in global teams and managing people/projects

Responsibilities:

• Oversees biomarker execution in clinical trials and supports biomarker sampling and subsequent data analysis
• Leads the development of asset specific translational goals and objectives for the Hematology Translational Medicine group
• Represents Translational Medicine on cross-functional strategy and global project teams
• Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory responses and answers to regulatory queries for the TM group
• Participate/present data at scientific advisory boards to support drug programs/projects
• Communicates regularly and prepares and makes presentations within the department and externally as required
• Responsible for selection and delivery of pharmacodynamic and biomarker assays including assessing the need and applicability for companion/complementary diagnostics for asset programs
• May perform advisory and mentoring role for junior scientists

Qualifications:

• PhD in Hematology/Oncology or related field with min 6 years in industry and academic setting
• Track record in drug discovery/development in large or small biotech/pharmaceutical companies, leading translational/biomarker studies or innovative efforts to deploy technologies and assays for enhanced translational capabilities or similar skill sets in academia
• Experience with translational/biomarker strategies for early or late stage clinical trials or investigator sponsored trials in academia

• The pay range for NJ Principal Level is between $140,000-$165,000.