Scientific Director, Clinical Development - Endocrinology
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
A responsible member of the clinical and program teams, dedicated to the development and execution of the clinical and translational strategy and program (scientific, clinical, and operational) of compounds in development, leveraging expertise in clinical trial methodology, statistical principles, and regulatory strategy. Directs study design, protocol development and execution of clinical research studies across all phases of clinical development through registration (NDA/MAA). Accountable for end-to-end execution of the process for each assigned clinical project in a timely and cost-effective manner. Contributes to interpretation and reporting of clinical study results. Leads multidisciplinary teams through complex decisions, integrating input from medical, scientific, regulatory, and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures, and serves as a resource to program teams for guidance on analysis and communication of clinical data. May participate in evaluation of business development opportunities. Responsibilities
Representative of the clinical team, dedicated to the development and execution of the clinical strategy and program (scientific, clinical) Provide recommendations and expertise to study teams and functional areas such as regulatory, clinical operations and line management Design clinical development plans and study protocols within assigned programs to yield high-value clinical insight for future critical decisions Lead effort within clinical development program teams to identify appropriate assessments and develop novel outcome measures for trials in early and late stages Manage development of target product profiles, clinical development plans, Investigator’s Brochures, study concepts/protocols, clinical study reports, regulatory documents, and other critical documents, in partnership with supporting departments Influence clinical teams through subject-matter expertise, research literature, and competitor activity; identify optimal study design, population selection, and endpoints Collaborate with external opinion leaders, internal clinicians, translational sciences and clinical operations to ensure study designs enable successful data analyses and outcomes Design trials from a patient-focused perspective and engage with opinion leaders and patient advocacy groups to inform study design and procedures Drive critical decisions including go/no-go decisions and dose selection Develop translational plans for disease models and biomarkers with research and pharmacology colleagues Work with commercial colleagues to develop clinical strategies for product positioning and reimbursement Coordinate with health economics and outcomes research to align clinical plans with real-world data Manage and support study and program teams to achieve goals within approved timeframes Provide timely and accurate monitoring of all study data (patient data, site data, source documents, etc.) Leverage data analytics and data science to produce insights before, during, and after a clinical study Monitor investigator adherence to protocols, regulatory requirements and good clinical practices; contribute to data validation plans Oversee site monitoring and facility audits, including site visits as needed Implement regulatory best practices and precedents in drug development for assigned programs Provide recommendations for regulatory document development for filings and agency meetings Review and interpret scientific knowledge of the competitor landscape Identify issues proactively and propose solutions Direct and manage team members to prepare abstracts, manuscripts, and presentations for external meetings and author clinical sections of regulatory documents Maintain up-to-date knowledge of pharmaceutical regulations, guidelines, practices and therapeutic area Maintain knowledge of ICH-GCP and external regulations required for regulatory filing Collaborate with bioanalytical labs, pharmacokinetic scientists, biomarker representatives, and data managers to ensure key PK/PD data are available for decisions Liaise with statisticians and programmers to develop and implement statistical analysis plans Evaluate and select clinical study centers and investigators Provide clinical support for Regulatory Affairs activities (health authority documents/responses, labeling, filings) Collaborate with safety physicians in monitoring adverse events, patient eligibility, and protocol deviations Interpret and present clinical results to internal and external audiences Prepare presentations and medical publications arising from the team Create and manage budgets for project-related activities with internal and external partners Review subject eligibility Mentor or develop clinical team members Qualifications
BS/BA degree in Biology, Chemistry, or related science field; 15+ years of relevant experience OR Master’s in Biology, Chemistry, or related science field; 13+ years of related experience OR PhD or equivalent combination of education and experience; 7+ years of related experience Knowledge of best practices in the functional discipline and familiarity with broader concepts of related business disciplines Strategic thinking with the ability to formulate, develop, and execute clinical strategies Ability to lead multiple teams and manage interdependent activities Strong leadership, communication, problem-solving, and analytical skills Ability to navigate cross-functional partnerships and influence stakeholders Excellent project management and computer literacy Ability to integrate external research findings into new scientific projects Deep knowledge of translational neuroscience and experience in developing medicines for mood disorders, schizophrenia or related psychiatry diseases Experience in designing and conducting Phase I–III studies in neuroscience Education
BS/BA in Biology, Chemistry, or related science field Master’s or PhD in Biology, Chemistry, or related science field (preferred)
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A responsible member of the clinical and program teams, dedicated to the development and execution of the clinical and translational strategy and program (scientific, clinical, and operational) of compounds in development, leveraging expertise in clinical trial methodology, statistical principles, and regulatory strategy. Directs study design, protocol development and execution of clinical research studies across all phases of clinical development through registration (NDA/MAA). Accountable for end-to-end execution of the process for each assigned clinical project in a timely and cost-effective manner. Contributes to interpretation and reporting of clinical study results. Leads multidisciplinary teams through complex decisions, integrating input from medical, scientific, regulatory, and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures, and serves as a resource to program teams for guidance on analysis and communication of clinical data. May participate in evaluation of business development opportunities. Responsibilities
Representative of the clinical team, dedicated to the development and execution of the clinical strategy and program (scientific, clinical) Provide recommendations and expertise to study teams and functional areas such as regulatory, clinical operations and line management Design clinical development plans and study protocols within assigned programs to yield high-value clinical insight for future critical decisions Lead effort within clinical development program teams to identify appropriate assessments and develop novel outcome measures for trials in early and late stages Manage development of target product profiles, clinical development plans, Investigator’s Brochures, study concepts/protocols, clinical study reports, regulatory documents, and other critical documents, in partnership with supporting departments Influence clinical teams through subject-matter expertise, research literature, and competitor activity; identify optimal study design, population selection, and endpoints Collaborate with external opinion leaders, internal clinicians, translational sciences and clinical operations to ensure study designs enable successful data analyses and outcomes Design trials from a patient-focused perspective and engage with opinion leaders and patient advocacy groups to inform study design and procedures Drive critical decisions including go/no-go decisions and dose selection Develop translational plans for disease models and biomarkers with research and pharmacology colleagues Work with commercial colleagues to develop clinical strategies for product positioning and reimbursement Coordinate with health economics and outcomes research to align clinical plans with real-world data Manage and support study and program teams to achieve goals within approved timeframes Provide timely and accurate monitoring of all study data (patient data, site data, source documents, etc.) Leverage data analytics and data science to produce insights before, during, and after a clinical study Monitor investigator adherence to protocols, regulatory requirements and good clinical practices; contribute to data validation plans Oversee site monitoring and facility audits, including site visits as needed Implement regulatory best practices and precedents in drug development for assigned programs Provide recommendations for regulatory document development for filings and agency meetings Review and interpret scientific knowledge of the competitor landscape Identify issues proactively and propose solutions Direct and manage team members to prepare abstracts, manuscripts, and presentations for external meetings and author clinical sections of regulatory documents Maintain up-to-date knowledge of pharmaceutical regulations, guidelines, practices and therapeutic area Maintain knowledge of ICH-GCP and external regulations required for regulatory filing Collaborate with bioanalytical labs, pharmacokinetic scientists, biomarker representatives, and data managers to ensure key PK/PD data are available for decisions Liaise with statisticians and programmers to develop and implement statistical analysis plans Evaluate and select clinical study centers and investigators Provide clinical support for Regulatory Affairs activities (health authority documents/responses, labeling, filings) Collaborate with safety physicians in monitoring adverse events, patient eligibility, and protocol deviations Interpret and present clinical results to internal and external audiences Prepare presentations and medical publications arising from the team Create and manage budgets for project-related activities with internal and external partners Review subject eligibility Mentor or develop clinical team members Qualifications
BS/BA degree in Biology, Chemistry, or related science field; 15+ years of relevant experience OR Master’s in Biology, Chemistry, or related science field; 13+ years of related experience OR PhD or equivalent combination of education and experience; 7+ years of related experience Knowledge of best practices in the functional discipline and familiarity with broader concepts of related business disciplines Strategic thinking with the ability to formulate, develop, and execute clinical strategies Ability to lead multiple teams and manage interdependent activities Strong leadership, communication, problem-solving, and analytical skills Ability to navigate cross-functional partnerships and influence stakeholders Excellent project management and computer literacy Ability to integrate external research findings into new scientific projects Deep knowledge of translational neuroscience and experience in developing medicines for mood disorders, schizophrenia or related psychiatry diseases Experience in designing and conducting Phase I–III studies in neuroscience Education
BS/BA in Biology, Chemistry, or related science field Master’s or PhD in Biology, Chemistry, or related science field (preferred)
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