Senior Clinical Research Director, Ophthalmology
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
The Senior Clinical Research Director (CRD) is an expert clinical lead for one or several indications in the development of an R&D program and is responsible for leading clinical teams to deliver successful clinical trials for novel therapeutics for ophthalmologic diseases. The role requires clinical leadership, strong organizational skills, strategic and operational focus, and the ability to coordinate with internal and external stakeholders. The position entails mentoring team members, delivering multiple operational tasks, and maintaining scientific and clinical credibility within the therapeutic area. Responsibilities
Provide ophthalmology-focused medical and scientific expertise to the cross-functional project team to conduct clinical studies from early phases to lifecycle management (LCM) programs Establish clinical development strategy and lead the clinical team; collaborate with medical and clinical science experts, regulatory, safety, statistics, and other functions to deliver development strategy and support regulatory interactions Develop or contribute to regulatory documentation; provide clinical leadership for study start-up activities such as risk assessment, patient engagement, and feasibility analyses Provide medical input and leadership for study conduct, including responses to IRB/HA questions, training, data review, and medical information support for study teams and investigators Oversee the clinical portion of regulatory documents (CTD) and respond to health authority questions Serve as the medical expert on the Clinical Study Team, mentoring other team members on medical/scientific strategy by indication Qualifications
Required: Medical Doctor (MD) with ophthalmology residency; fellowship training highly preferred Required: Minimum 5 years of clinical trial and/or clinical development experience Required: Fluent in English (verbal and written) Preferred: Board certified or eligible in Ophthalmology Preferred: Strong scientific background with deep understanding of retina and eye diseases; experience in ophthalmology clinical trials or pharmaceutical development Preferred: Knowledge of drug development, ocular gene therapy, regulatory strategy; ability to network across cultures Preferred: Excellent interpersonal, communication, presentation, and negotiation skills; ability to work to timelines and focus on strategy and execution Preferred: Ability to lead and collaborate with cross-functional teams and external stakeholders Skills
Deep expertise in ophthalmology and retinal diseases Strong ability to interpret pre-clinical and clinical pharmacology data and read medical literature critically Medical monitoring and regulatory writing capabilities; proficiency in CTD, SAP input, and clinical documentation Excellent communication, leadership, mentoring, and collaboration skills Strategic thinking with operational execution and problem-solving abilities Education
Medical Doctor (MD) with ophthalmology residency; fellowship training highly preferred
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The Senior Clinical Research Director (CRD) is an expert clinical lead for one or several indications in the development of an R&D program and is responsible for leading clinical teams to deliver successful clinical trials for novel therapeutics for ophthalmologic diseases. The role requires clinical leadership, strong organizational skills, strategic and operational focus, and the ability to coordinate with internal and external stakeholders. The position entails mentoring team members, delivering multiple operational tasks, and maintaining scientific and clinical credibility within the therapeutic area. Responsibilities
Provide ophthalmology-focused medical and scientific expertise to the cross-functional project team to conduct clinical studies from early phases to lifecycle management (LCM) programs Establish clinical development strategy and lead the clinical team; collaborate with medical and clinical science experts, regulatory, safety, statistics, and other functions to deliver development strategy and support regulatory interactions Develop or contribute to regulatory documentation; provide clinical leadership for study start-up activities such as risk assessment, patient engagement, and feasibility analyses Provide medical input and leadership for study conduct, including responses to IRB/HA questions, training, data review, and medical information support for study teams and investigators Oversee the clinical portion of regulatory documents (CTD) and respond to health authority questions Serve as the medical expert on the Clinical Study Team, mentoring other team members on medical/scientific strategy by indication Qualifications
Required: Medical Doctor (MD) with ophthalmology residency; fellowship training highly preferred Required: Minimum 5 years of clinical trial and/or clinical development experience Required: Fluent in English (verbal and written) Preferred: Board certified or eligible in Ophthalmology Preferred: Strong scientific background with deep understanding of retina and eye diseases; experience in ophthalmology clinical trials or pharmaceutical development Preferred: Knowledge of drug development, ocular gene therapy, regulatory strategy; ability to network across cultures Preferred: Excellent interpersonal, communication, presentation, and negotiation skills; ability to work to timelines and focus on strategy and execution Preferred: Ability to lead and collaborate with cross-functional teams and external stakeholders Skills
Deep expertise in ophthalmology and retinal diseases Strong ability to interpret pre-clinical and clinical pharmacology data and read medical literature critically Medical monitoring and regulatory writing capabilities; proficiency in CTD, SAP input, and clinical documentation Excellent communication, leadership, mentoring, and collaboration skills Strategic thinking with operational execution and problem-solving abilities Education
Medical Doctor (MD) with ophthalmology residency; fellowship training highly preferred
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