Clinical Research Director - Oncology
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. As a Senior Clinical Research Director (Senior CRD) within the Oncology Therapeutic Area, you will lead the clinical trial strategy for one or more multiple myeloma assets, creating synergies across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. Responsibilities
Working within a matrix model, establish or adapt clinical development and contigency plans by engaging with clinical investigators, advisors and regulatory authorities. Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports, development risk management plans. Lead the clinical interpretation of study results Contributes to clinical study reports and clinical summaries, including regulatory submissions. Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities Author clinical abstracts, presentations for conferences, and manuscripts Education
Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies is a plus. Experience
At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution Soft Skills
Excellent communication skills (verbal and written English) with both internal and external stakeholders Adept at problem solving Thoughtful risk-taking: challenge decisions and status quo with a risk-management approach Demonstrated ability to work with a multi-functional team to achieve project milestones. Understanding of and willingness to meet applicable regulatory, quality and compliance standards. Quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions International/ intercultural working skills
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Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. As a Senior Clinical Research Director (Senior CRD) within the Oncology Therapeutic Area, you will lead the clinical trial strategy for one or more multiple myeloma assets, creating synergies across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. Responsibilities
Working within a matrix model, establish or adapt clinical development and contigency plans by engaging with clinical investigators, advisors and regulatory authorities. Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports, development risk management plans. Lead the clinical interpretation of study results Contributes to clinical study reports and clinical summaries, including regulatory submissions. Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities Author clinical abstracts, presentations for conferences, and manuscripts Education
Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies is a plus. Experience
At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution Soft Skills
Excellent communication skills (verbal and written English) with both internal and external stakeholders Adept at problem solving Thoughtful risk-taking: challenge decisions and status quo with a risk-management approach Demonstrated ability to work with a multi-functional team to achieve project milestones. Understanding of and willingness to meet applicable regulatory, quality and compliance standards. Quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions International/ intercultural working skills
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