Development Scientific Director, Ophthalmology
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
The Development Scientific Director (DSD) is a clinical team member responsible for developing and executing clinical strategies and implementing complex compound programs clinically and operationally. The role supports the Clinical Research Director and/or clinical lead in medical/scientific contributions for clinical studies, from development plans and trial setup to clinical study reports in compliance with quality and regulatory processes.
Responsibilities
Provide active scientific contribution to a cross-functional clinical team developing a molecular entity, input to the clinical development plan, development of the clinical trial protocol and materials, coordinate completion of clinical study reports, and support preparation of regulatory documents.
Lead or represent clinical development across specific aspects of clinical trial execution with extensive cross-disciplinary matrix interactions.Contribute to the evaluation of scientific opportunities within the therapeutic area.
Collaborate with Coding specialists, Biostatisticians, Data Managers, Global/Regional Study Managers, Feasibility Managers, Pharmacovigilance, and Medical Writers on high-quality medical scientific documents as needed.
Ensure review and consistency of data and investigations of safety cases with the Clinical Trial Team or Pharmacovigilance.
Qualifications
Required: Ophthalmology/retina clinical development experience and clinical trial methodology knowledge; leadership skills to guide activities on behalf of the CRD; ability to synthesize scientific information and present it effectively; experience drafting protocols/amendments and providing input to CSRs and regulatory documents (IBs/INDs, briefing books); familiarity with data analytics or digital tools; quality-focused with data-driven, risk-based approach; ability to work autonomously, provide status reports, and elevate issues as needed; strong organizational skills and motivation; excellent verbal and written communication; ability to manage multiple tasks and prioritize; ability to work in a project-mode with study teams and CRDs; strong leadership and collaboration across cross-functional teams; team and results orientation; international experience with strong English skills; travel up to 15%.
Required: Ph.D. preferred; Masters degree considered with extensive experience; minimum 3 years of phase I-III clinical trial/drug development experience in ophthalmology/retina industry or CRO; knowledge of ICH/GCP; fluent in English.
Education
Ph.D. preferred; Masters degree considered for candidates with extensive experience.
A minimum of 3 years of phase I-III clinical trial/drug development experience within ophthalmology/retina industry or CRO.
Knowledge of ICH, GCP; fluent in English.
Skills
Clinical development leadership
Scientific writing and regulatory documentation
Cross-functional collaboration and stakeholder management
Data interpretation and risk management
Strong communication and presentation skills
Additional Requirements
Travel up to 15% may be required.
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Responsibilities
Provide active scientific contribution to a cross-functional clinical team developing a molecular entity, input to the clinical development plan, development of the clinical trial protocol and materials, coordinate completion of clinical study reports, and support preparation of regulatory documents.
Lead or represent clinical development across specific aspects of clinical trial execution with extensive cross-disciplinary matrix interactions.Contribute to the evaluation of scientific opportunities within the therapeutic area.
Collaborate with Coding specialists, Biostatisticians, Data Managers, Global/Regional Study Managers, Feasibility Managers, Pharmacovigilance, and Medical Writers on high-quality medical scientific documents as needed.
Ensure review and consistency of data and investigations of safety cases with the Clinical Trial Team or Pharmacovigilance.
Qualifications
Required: Ophthalmology/retina clinical development experience and clinical trial methodology knowledge; leadership skills to guide activities on behalf of the CRD; ability to synthesize scientific information and present it effectively; experience drafting protocols/amendments and providing input to CSRs and regulatory documents (IBs/INDs, briefing books); familiarity with data analytics or digital tools; quality-focused with data-driven, risk-based approach; ability to work autonomously, provide status reports, and elevate issues as needed; strong organizational skills and motivation; excellent verbal and written communication; ability to manage multiple tasks and prioritize; ability to work in a project-mode with study teams and CRDs; strong leadership and collaboration across cross-functional teams; team and results orientation; international experience with strong English skills; travel up to 15%.
Required: Ph.D. preferred; Masters degree considered with extensive experience; minimum 3 years of phase I-III clinical trial/drug development experience in ophthalmology/retina industry or CRO; knowledge of ICH/GCP; fluent in English.
Education
Ph.D. preferred; Masters degree considered for candidates with extensive experience.
A minimum of 3 years of phase I-III clinical trial/drug development experience within ophthalmology/retina industry or CRO.
Knowledge of ICH, GCP; fluent in English.
Skills
Clinical development leadership
Scientific writing and regulatory documentation
Cross-functional collaboration and stakeholder management
Data interpretation and risk management
Strong communication and presentation skills
Additional Requirements
Travel up to 15% may be required.
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