Senior Clinical Research Director - Oncology
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
Senior Clinical Research Director within the Oncology Therapeutic Area, leading the clinical trial strategy for one or more multiple myeloma assets, aligning with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish and execute the development plan. Responsibilities
Working within a matrix model, establish or adapt clinical development and contingency 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 Qualifications
Education: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies. 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; 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, open to data-driven approaches and new digital solutions; international/intercultural working skills.
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Senior Clinical Research Director within the Oncology Therapeutic Area, leading the clinical trial strategy for one or more multiple myeloma assets, aligning with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish and execute the development plan. Responsibilities
Working within a matrix model, establish or adapt clinical development and contingency 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 Qualifications
Education: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies. 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; 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, open to data-driven approaches and new digital solutions; international/intercultural working skills.
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