Clinical Research Director (CRD), Rare Diseases
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
The Clinical Research Director (CRD), Rare Diseases Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects/studies in this TA. The CRD develops the clinical development plan aligned with the project strategy, obtains governance endorsement, and executes in close collaboration with clinical operations. The role advances scientific and clinical knowledge and leads clinical study development in alignment with asset strategy, with an initial focus in the pulmonary space. The CRD contributes to the growth of the Rare Blood Disorders TA by driving clinical and scientific knowledge and advancing operational capabilities. 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
Scientific, technical and clinical expertise in the therapeutic area Understanding of pre-clinical, clinical pharmacology and data relevant to the molecule of interest Ability to critically read and evaluate medical literature with deep understanding of data and competitive products Visibility within the therapy area to maintain credibility with internal and external stakeholders Designs global clinical development strategy and leads ongoing development activities and labeling changes in collaboration with Regulatory Affairs and Health Economics Assessment of the clinical benefit–risk profile during development and lifecycle management with cross-functional teams Provides clinical input to Target Product Profile and life cycle management Adjusts clinical strategy as project progresses and information becomes available Represents clinical development in project teams, regulatory meetings, steering committees, data monitoring committees, and submission task forces Generates and reviews clinical development documents, CTD sections, and regulatory responses, and oversees medical/clinical assessment of license-in opportunities Maintains deep scientific and clinical expertise; keeps up-to-date with literature and data in the therapeutic area Strong leadership and communication skills; demonstrated ability to influence in a matrix environment Proven track record of scientific publications and presentations at international conferences Qualifications
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years of relevant experience in clinical development within the pharmaceutical industry, academia, or government/regulatory bodies Experience advancing assets from discovery into clinical development and enthusiasm for translational medicine Experience with novel translational medicine approaches Strong problem-solving abilities Ability to stay current with pre-clinical, clinical pharmacology and data relevant to the molecule and therapeutic area Strong leadership with ability to influence and collaborate 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 Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects/studies in this TA. The CRD develops the clinical development plan aligned with the project strategy, obtains governance endorsement, and executes in close collaboration with clinical operations. The role advances scientific and clinical knowledge and leads clinical study development in alignment with asset strategy, with an initial focus in the pulmonary space. The CRD contributes to the growth of the Rare Blood Disorders TA by driving clinical and scientific knowledge and advancing operational capabilities. 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
Scientific, technical and clinical expertise in the therapeutic area Understanding of pre-clinical, clinical pharmacology and data relevant to the molecule of interest Ability to critically read and evaluate medical literature with deep understanding of data and competitive products Visibility within the therapy area to maintain credibility with internal and external stakeholders Designs global clinical development strategy and leads ongoing development activities and labeling changes in collaboration with Regulatory Affairs and Health Economics Assessment of the clinical benefit–risk profile during development and lifecycle management with cross-functional teams Provides clinical input to Target Product Profile and life cycle management Adjusts clinical strategy as project progresses and information becomes available Represents clinical development in project teams, regulatory meetings, steering committees, data monitoring committees, and submission task forces Generates and reviews clinical development documents, CTD sections, and regulatory responses, and oversees medical/clinical assessment of license-in opportunities Maintains deep scientific and clinical expertise; keeps up-to-date with literature and data in the therapeutic area Strong leadership and communication skills; demonstrated ability to influence in a matrix environment Proven track record of scientific publications and presentations at international conferences Qualifications
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years of relevant experience in clinical development within the pharmaceutical industry, academia, or government/regulatory bodies Experience advancing assets from discovery into clinical development and enthusiasm for translational medicine Experience with novel translational medicine approaches Strong problem-solving abilities Ability to stay current with pre-clinical, clinical pharmacology and data relevant to the molecule and therapeutic area Strong leadership with ability to influence and collaborate 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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