Clinical Research Director (CRD), Rare Diseases
Scorpion Therapeutics, Convent Station, New Jersey, us, 07961
Role Summary
The Clinical Research Director (CRD), Rare Diseases, is responsible for the creation and execution of the clinical development strategy for assigned projects within the Rare Diseases therapeutic area. The role leads the clinical development plan in alignment with project strategy and governance and collaborates with clinical operations to execute. It aims to advance scientific and clinical knowledge, lead study development, and support innovative therapies, with an initial focus in the pulmonary space. Location: Cambridge, MA; Morristown, NJ. Responsibilities
Create clinical development strategy and plans for one or more assets Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing Advance the clinical development plan through internal management review Lead a clinical sub team to design clinical studies and to create study protocols Execute the clinical development plan in close collaboration with clinical operations Advance scientific and clinical knowledge in rare diseases Incorporate new trial, scientific and digital methodologies Pro-actively progress study execution Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews) Serve as a medical expert and provide strategic input to early-stage programs Collaborate with external experts, key opinion leaders, and investigators to advance clinical research Represent Sanofi at scientific conferences and regulatory meetings Skills
Has and maintains deep scientific, technical and clinical expertise in the therapeutic area Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the therapy therapeutic area to maintain credibility with internal and external stakeholders Qualifications
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia) Have experience in novel approaches to translational medicine Demonstrate problem solving skills Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences Proven track record of scientific publications and presentations at international conferences
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The Clinical Research Director (CRD), Rare Diseases, is responsible for the creation and execution of the clinical development strategy for assigned projects within the Rare Diseases therapeutic area. The role leads the clinical development plan in alignment with project strategy and governance and collaborates with clinical operations to execute. It aims to advance scientific and clinical knowledge, lead study development, and support innovative therapies, with an initial focus in the pulmonary space. Location: Cambridge, MA; Morristown, NJ. Responsibilities
Create clinical development strategy and plans for one or more assets Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing Advance the clinical development plan through internal management review Lead a clinical sub team to design clinical studies and to create study protocols Execute the clinical development plan in close collaboration with clinical operations Advance scientific and clinical knowledge in rare diseases Incorporate new trial, scientific and digital methodologies Pro-actively progress study execution Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews) Serve as a medical expert and provide strategic input to early-stage programs Collaborate with external experts, key opinion leaders, and investigators to advance clinical research Represent Sanofi at scientific conferences and regulatory meetings Skills
Has and maintains deep scientific, technical and clinical expertise in the therapeutic area Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the therapy therapeutic area to maintain credibility with internal and external stakeholders Qualifications
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia) Have experience in novel approaches to translational medicine Demonstrate problem solving skills Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences Proven track record of scientific publications and presentations at international conferences
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