Senior Clinical Research Director, Rare
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
Senior Clinical Research Director (Senior CRD) within the RARE Therapeutic Area, acting as the expert clinical lead for one or several indications in the development of an R&D program. The role requires medical leadership, strong organizational skills, and a strategic and operational focus. The Senior CRD drives synergy within the team and with external stakeholders, demonstrates emotional intelligence, self-motivation, analytical capability, and the ability to manage multiple operational tasks. Responsibilities
Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global Safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…) Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answers to questions from health authorities Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, with capacity to train them on the medical/scientific strategy by indication Responsibilities
Leading the clinical development plan strategies:
Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams Raise study or project-level issues to the project head and propose related corrective action plans Collaborates with external partners, regulators, scientific experts and internal stakeholders Provide operational expertise to project clinical sub team, as needed Evaluates relevant medical literature and status from competitive products Responsibilities
Lead, Support and oversee the execution of clinical development and studies activities Collaborate and communicate appropriately with all function stakeholders (e.g., clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement, etc.), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with GCP, laws and SOPs Develop the abbreviated protocol, the final protocol and protocol amendments Develop/review the Core Study Informed Consent Form (CSICF) Develop/review Study committee Charters Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results Review and provide clinical input across study documents such as Vendors RFPs, (e-)CRF, (e-) diary, (e-)CoA, etc. Provide medical/clinical input to study-related documents such as study plans (e.g., Study risk management plan, Monitoring and centralized monitoring plans) Participate in the elaboration of training material and presentations at investigator meetings/local team trainings Answer medical questions raised by HA, EC/IRBs, sites Ensure quality of clinical data through continuous data validation, blinded data review on summary tables or electronic data visualization during clinical trial conduct Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function Lead the study-specific committees (IDMC, steering committee, adjudication, etc.) with operational support Co-Develop the SAP in collaboration with biostats Responsible for key results preparation Develop/Review the clinical study report Responsibilities
Regulatory and Safety Documents and Meetings Represent project in interactions with regulatory bodies, lead strategy and write clinical sections of the CTD, briefing docs and supports registration, labeling etc. Develop and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Ensure clinical data meets regulatory standards Collaborate with the Patient Safety Global Safety Officer to detect and document any safety signal Participates in Advisory Committee preparation Qualifications
Required: At least 4 years of experience in clinical development in the pharmaceutical industry or a CRO, or medical experience in clinical development within a healthcare institution Preferred: Medical Doctor (MD) with GP or specialist training; pediatrics or pediatric neurology is a plus Skills
Very good communication skills (verbal and written) for interactions across functional areas and with regulatory agencies Excellent problem-solving capability Ability to challenge decisions with a risk-management approach Quality-focused with data-driven and risk-management mindset Multitasking and prioritization abilities Negotiation to secure operational resources for continued clinical conduct Mentoring skills and evaluation of resource performance Ability to work within a matrix model International/intercultural working skills Open-minded to applying new digital solutions Education
Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus Languages
English fluent (spoken and written)
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Senior Clinical Research Director (Senior CRD) within the RARE Therapeutic Area, acting as the expert clinical lead for one or several indications in the development of an R&D program. The role requires medical leadership, strong organizational skills, and a strategic and operational focus. The Senior CRD drives synergy within the team and with external stakeholders, demonstrates emotional intelligence, self-motivation, analytical capability, and the ability to manage multiple operational tasks. Responsibilities
Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global Safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…) Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answers to questions from health authorities Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, with capacity to train them on the medical/scientific strategy by indication Responsibilities
Leading the clinical development plan strategies:
Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams Raise study or project-level issues to the project head and propose related corrective action plans Collaborates with external partners, regulators, scientific experts and internal stakeholders Provide operational expertise to project clinical sub team, as needed Evaluates relevant medical literature and status from competitive products Responsibilities
Lead, Support and oversee the execution of clinical development and studies activities Collaborate and communicate appropriately with all function stakeholders (e.g., clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement, etc.), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with GCP, laws and SOPs Develop the abbreviated protocol, the final protocol and protocol amendments Develop/review the Core Study Informed Consent Form (CSICF) Develop/review Study committee Charters Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results Review and provide clinical input across study documents such as Vendors RFPs, (e-)CRF, (e-) diary, (e-)CoA, etc. Provide medical/clinical input to study-related documents such as study plans (e.g., Study risk management plan, Monitoring and centralized monitoring plans) Participate in the elaboration of training material and presentations at investigator meetings/local team trainings Answer medical questions raised by HA, EC/IRBs, sites Ensure quality of clinical data through continuous data validation, blinded data review on summary tables or electronic data visualization during clinical trial conduct Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function Lead the study-specific committees (IDMC, steering committee, adjudication, etc.) with operational support Co-Develop the SAP in collaboration with biostats Responsible for key results preparation Develop/Review the clinical study report Responsibilities
Regulatory and Safety Documents and Meetings Represent project in interactions with regulatory bodies, lead strategy and write clinical sections of the CTD, briefing docs and supports registration, labeling etc. Develop and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Ensure clinical data meets regulatory standards Collaborate with the Patient Safety Global Safety Officer to detect and document any safety signal Participates in Advisory Committee preparation Qualifications
Required: At least 4 years of experience in clinical development in the pharmaceutical industry or a CRO, or medical experience in clinical development within a healthcare institution Preferred: Medical Doctor (MD) with GP or specialist training; pediatrics or pediatric neurology is a plus Skills
Very good communication skills (verbal and written) for interactions across functional areas and with regulatory agencies Excellent problem-solving capability Ability to challenge decisions with a risk-management approach Quality-focused with data-driven and risk-management mindset Multitasking and prioritization abilities Negotiation to secure operational resources for continued clinical conduct Mentoring skills and evaluation of resource performance Ability to work within a matrix model International/intercultural working skills Open-minded to applying new digital solutions Education
Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus Languages
English fluent (spoken and written)
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