Senior Clinical Research Director, I&I
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs. The role requires a well-organized, strategically focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver across multiple operational tasks. Responsibilities
Act as a mentor for other CRDs and Clinical Scientists on the same project/therapeutic area Collaborate with functions to ensure a uniform, aligned operational approach (e.g., harmonizing study documents, essential studies, protocols, etc.). Within a project, provide leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipate potential issues, and share lessons learned across project teams. Raise study or project-level issues to TA Heads as relevant and share information within and beyond project teams Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (e.g., protocol, Key Results, Clinical Study Report) Support other clinical development activities (e.g., stress testing and cluster feasibility, medical review and validation of clinical data, study risk assessment) Contribute to the clinical part of submission dossiers for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities Provide appropriate medical input and support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Internal Governance: Preparation of documents and presentations for Internal Governance Meetings Contribute to the definition of the product value proposition (TVP), target product profile (TPP) and market access strategy, collaborating with respective functions, shaping the research strategy and clinical development approaches for research projects Represent the project at key regulatory agency meetings as the medical spokesperson; lead the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP; support registrations, label submissions and modifications When necessary, assume the CRD role inside the project Review and/or contribute to the clinical sections of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP Ad hoc contributions to tasks such as evaluating potential in-licensing candidates for the I&I therapeutic area and serve as the clinical advisor to research teams Qualifications
Required:
Medical Doctor (MD) or equivalent; English fluent (spoken and written) Preferred:
MD: GP or specialist Required:
At least 4 years in pharmaceutical industry or CRO, previous experience in clinical development
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The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs. The role requires a well-organized, strategically focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver across multiple operational tasks. Responsibilities
Act as a mentor for other CRDs and Clinical Scientists on the same project/therapeutic area Collaborate with functions to ensure a uniform, aligned operational approach (e.g., harmonizing study documents, essential studies, protocols, etc.). Within a project, provide leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipate potential issues, and share lessons learned across project teams. Raise study or project-level issues to TA Heads as relevant and share information within and beyond project teams Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (e.g., protocol, Key Results, Clinical Study Report) Support other clinical development activities (e.g., stress testing and cluster feasibility, medical review and validation of clinical data, study risk assessment) Contribute to the clinical part of submission dossiers for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities Provide appropriate medical input and support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Internal Governance: Preparation of documents and presentations for Internal Governance Meetings Contribute to the definition of the product value proposition (TVP), target product profile (TPP) and market access strategy, collaborating with respective functions, shaping the research strategy and clinical development approaches for research projects Represent the project at key regulatory agency meetings as the medical spokesperson; lead the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP; support registrations, label submissions and modifications When necessary, assume the CRD role inside the project Review and/or contribute to the clinical sections of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP Ad hoc contributions to tasks such as evaluating potential in-licensing candidates for the I&I therapeutic area and serve as the clinical advisor to research teams Qualifications
Required:
Medical Doctor (MD) or equivalent; English fluent (spoken and written) Preferred:
MD: GP or specialist Required:
At least 4 years in pharmaceutical industry or CRO, previous experience in clinical development
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