Medical Director Global Metabolism/Neurology View job details of “Medical Director Global Metabolism/Neurology

The Medical Director will ensure the medical and scientific integrity of clinical trials conducted by the Company in the therapeutic area of Metabolism/Neurology.

Preferred Education and Experience

·         MD, board-certified (or eligible) preferably in Endocrinology, Gastroenterology or Neurology

·         Requires at least 5 years of relevant clinical development experience.

·         Relevant basic and/or clinical research experience in academic settings is viewed favorably.

Essential Duties/Tasks

·         Act as a clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs.

·         Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question.

·         Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs.

·         Design, develop and implement clinical studies for the applicable drug candidate, from Phase I through Phase III.

·         Develop and participate in the writing and review of protocols, investigator brochures, study reports, and other clinical and regulatory documents.

·         Establish and approve scientific methods for the design and implementation of applicable clinical protocols, data collection systems, and final reports.

·         Acts to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee.

·         Play a key role in the analysis, interpretation, and delivery of high-quality clinical data.

·         Interact with principal investigators and opinion leaders to facilitate clinical trials research.

·         Participate in appropriate regulatory discussions and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle.

·         Participate in clinical study report conceptualization, development, and writing for global regulatory submissions.

·         Work closely and collaboratively with other functions, e.g., clinical operations, safety, biometrics, regulatory, medical writing, medical affairs, and commercial.

·         Develop and give internal and external presentations as subject matter experts for the therapeutic area.

·         Participate in the development and review of publications.

·         Prepare and monitor budgets in collaboration with clinical operations and R&D finance

·         Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.

·         Serve as liaison to the commercial team on medical issues.

Preferred Skills, Qualifications, or Technical Proficiencies

·         Strong clinical and scientific knowledge

·         Excellent communicator with proven leadership skills and the ability to interact in a cross-functional environment.

·         Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities.

Job Requirements:

The Medical Director will ensure the medical and scientific integrity of clinical trials conducted by the Company in the therapeutic area of Metabolism/Neurology.

Preferred Education and Experience

·         MD, board-certified (or eligible) preferably in Endocrinology, Gastroenterology or Neurology

·         Requires at least 5 years of relevant clinical development experience.

·         Relevant basic and/or clinical research experience in academic settings is viewed favorably.

Essential Duties/Tasks

·         Act as a clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs.

·         Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question.

·         Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs.

·         Design, develop and implement clinical studies for the applicable drug candidate, from Phase I through Phase III.

·         Develop and participate in the writing and review of protocols, investigator brochures, study reports, and other clinical and regulatory documents.

·         Establish and approve scientific methods for the design and implementation of applicable clinical protocols, data collection systems, and final reports.

·         Acts to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee.

·         Play a key role in the analysis, interpretation, and delivery of high-quality clinical data.

·         Interact with principal investigators and opinion leaders to facilitate clinical trials research.

·         Participate inappropriate regulatory discussions and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle.

·         Participate in clinical study report conceptualization, development, and writing for global regulatory submissions.

·         Work closely and collaboratively with other functions, e.g., clinical operations, safety, biometrics, regulatory, medical writing, medical affairs, and commercial.

·         Develop and give internal and external presentations as subject matter experts for the therapeutic area.

·         Participate in the development and review of publications.

·         Prepare and monitor budgets in collaboration with clinical operations and R&D finance

·         Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.

·         Serve as liaison to the commercial team on medical issues.

Preferred Skills, Qualifications, or Technical Proficiencies

·         Strong clinical and scientific knowledge

·         Excellent communicator with proven leadership skills and the ability to interact in a cross-functional environment.

·         Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities.