Senior Clinical Research Director - Oncology
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
Role Summary
Senior Clinical Research Director (Senior CRD) within the Oncology Therapeutic Area, leading the clinical trial strategy for one or more multiple myeloma assets. Collaborates across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. Location is Cambridge, MA or Morristown, NJ with preferred locations noted as Cambridge, MA; Morristown, NJ and Vitry, France considered.
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:
Required: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology. Preferred: experience in myeloma or hematologic malignancies.
Experience:
Required: At least 4 years of 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 and data-driven; international/intercultural working skills.
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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:
Required: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology. Preferred: experience in myeloma or hematologic malignancies.
Experience:
Required: At least 4 years of 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 and data-driven; international/intercultural working skills.
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