Development Scientifc Director, I&I
Scorpion Therapeutics, Convent Station, New Jersey, us, 07961
Role Summary
The Development Scientific Director (DSD) is a key scientific lead for development programs, providing clinical scientific expertise across studies and contributing to regulatory submissions. The role requires an organized, operationally focused, resourceful professional with strong emotional intelligence, self-motivation and analytical skills, capable of delivering multiple tasks. Location: Morristown, NJ; Cambridge, MA. Responsibilities
Provide expertise and act as a reference for all clinical scientific operational activities related to the projects/studies assigned. Write/contribute/review/QC/validate study-related documents: clinical protocols, written subject information, trial disclosure form, Case Report Form, study plans (e.g., study risk management plan, central monitoring plan), study reports, and training/meeting materials. Contribute to publications and communications of results. Collaborate and communicate with stakeholders for optimal study execution, including but not limited to: Provide input to the study extended synopsis and protocol based on feasibility pre-assessment, protocol complexity index and assist in determining associated cost. Support the overall supervision/execution of clinical scientific validation/review of study data, including writing or supervision of study-related documents (e.g., medical review plan, guidelines). Organize/contribute to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (e.g., charter, presentations). Provide clinical scientific answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts and the clinical study team. Ensure readiness and availability of trial master file documents and mandatory trainings linked to the clinical function. Review/approve study-related documents (e.g., vendor specifications for centralized services, CRF, CRF completion guidance, patient diary). Interact with Medical Writers to develop, review and finalize study protocols and reports. Maintain clinical scientific expertise in the therapeutic domain, including understanding of underlying disease biology and translation to development programs, and contribute to disease biomarker plans; maintain understanding of disease pathophysiology, disease subtypes and clinical management. Collaborate with functions to ensure a uniform, aligned operational approach within a project; lead, build consensus, coordinate action plans with other development colleagues and stakeholders to resolve project-related study issues; anticipate potential issues and share lessons learned across project or study teams. Provide operational expertise to the project clinical sub-team, as needed. Support the drafting of the extended synopsis of studies and subsequent protocol, contribute to the clinical development plans (CDP), review of Investigator’s brochures, and oversee the execution of such plans by the respective operational units in compliance with SOP, GCP and other regulations. With support from related Sanofi functions (clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials. Support the team with defending the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable; contribute to strategies to increase understanding of the mechanism of action of the drug including the identification of biomarkers; on an ad hoc basis contribute to evaluations of potential in-licensing candidates. Qualifications
Understanding of pharmaceutical product development and life cycle management gained through at least 2 years of development and clinical scientific experience. Very good scientific expertise. Very good expertise in clinical development and methodology of clinical studies. Very good communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies. Demonstrated capability to challenge decisions and apply a risk-management approach. Ability to negotiate to ensure operational resources are available for continued clinical conduct. Fluency in written and spoken English. Very good teaching skills, demonstrated ability to assist and train others. Ability to work within a matrix model. Advanced degree such as PhD in Life Science or Health Science related field. MPH or Biomedical Science master combined with extensive drug development experience may be considered. At least 3 years previous experience in clinical development in the pharmaceutical industry or a CRO, or experience in clinical development in a healthcare institution. Education
Advanced degree such as PhD, in a Life Science or Health Science related field. MPH or Biomedical Science master's with extensive drug development experience may be considered.
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The Development Scientific Director (DSD) is a key scientific lead for development programs, providing clinical scientific expertise across studies and contributing to regulatory submissions. The role requires an organized, operationally focused, resourceful professional with strong emotional intelligence, self-motivation and analytical skills, capable of delivering multiple tasks. Location: Morristown, NJ; Cambridge, MA. Responsibilities
Provide expertise and act as a reference for all clinical scientific operational activities related to the projects/studies assigned. Write/contribute/review/QC/validate study-related documents: clinical protocols, written subject information, trial disclosure form, Case Report Form, study plans (e.g., study risk management plan, central monitoring plan), study reports, and training/meeting materials. Contribute to publications and communications of results. Collaborate and communicate with stakeholders for optimal study execution, including but not limited to: Provide input to the study extended synopsis and protocol based on feasibility pre-assessment, protocol complexity index and assist in determining associated cost. Support the overall supervision/execution of clinical scientific validation/review of study data, including writing or supervision of study-related documents (e.g., medical review plan, guidelines). Organize/contribute to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (e.g., charter, presentations). Provide clinical scientific answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts and the clinical study team. Ensure readiness and availability of trial master file documents and mandatory trainings linked to the clinical function. Review/approve study-related documents (e.g., vendor specifications for centralized services, CRF, CRF completion guidance, patient diary). Interact with Medical Writers to develop, review and finalize study protocols and reports. Maintain clinical scientific expertise in the therapeutic domain, including understanding of underlying disease biology and translation to development programs, and contribute to disease biomarker plans; maintain understanding of disease pathophysiology, disease subtypes and clinical management. Collaborate with functions to ensure a uniform, aligned operational approach within a project; lead, build consensus, coordinate action plans with other development colleagues and stakeholders to resolve project-related study issues; anticipate potential issues and share lessons learned across project or study teams. Provide operational expertise to the project clinical sub-team, as needed. Support the drafting of the extended synopsis of studies and subsequent protocol, contribute to the clinical development plans (CDP), review of Investigator’s brochures, and oversee the execution of such plans by the respective operational units in compliance with SOP, GCP and other regulations. With support from related Sanofi functions (clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials. Support the team with defending the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable; contribute to strategies to increase understanding of the mechanism of action of the drug including the identification of biomarkers; on an ad hoc basis contribute to evaluations of potential in-licensing candidates. Qualifications
Understanding of pharmaceutical product development and life cycle management gained through at least 2 years of development and clinical scientific experience. Very good scientific expertise. Very good expertise in clinical development and methodology of clinical studies. Very good communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies. Demonstrated capability to challenge decisions and apply a risk-management approach. Ability to negotiate to ensure operational resources are available for continued clinical conduct. Fluency in written and spoken English. Very good teaching skills, demonstrated ability to assist and train others. Ability to work within a matrix model. Advanced degree such as PhD in Life Science or Health Science related field. MPH or Biomedical Science master combined with extensive drug development experience may be considered. At least 3 years previous experience in clinical development in the pharmaceutical industry or a CRO, or experience in clinical development in a healthcare institution. Education
Advanced degree such as PhD, in a Life Science or Health Science related field. MPH or Biomedical Science master's with extensive drug development experience may be considered.
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