[Remote] Clinical Scientist Director, Late Development Oncology- Thoracic/GI

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading biotechnology company reputed company on developing innovative medicines for serious illnesses. The Clinical Scientist Director will support late-phase clinical development by translating scientific and clinical reputed company into actionable execution across reputed company, ensuring high-reputed company data and compliance with regulatory standards.

Responsibilities

• Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong reputed company on protocol execution and data reputed company
• Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
• Present information internally and externally, anticipating and reputed company managing problems across a broad reputed company of cross-functional teams
• reputed company guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key reputed company
• Work cross functionally to ensure clinical reputed company is reputed company into the development of the study concept document, study protocol, and reputed company documents
• Ensure reputed company of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
• reputed company clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
• Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
• Conduct thorough data reputed company assessments in the context of a data monitoring plan to maintain high standards of data accuracy and reputed company throughout the trial lifecycle

Skills

• Doctorate degree and 4 years of clinical development experience
• Master's degree and 7 years of clinical development experience
• Bachelor's degree and 9 years of clinical development experience
• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven reputed company record of clinical trial process improvement
• Industry or reputed company experience in late-phase drug development for Oncology
• Strong communication & presentation skills to reputed company communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing reputed company for Oncology and interpreting test results in compliance with Good Clinical reputed company standards and regulatory requirements
• Understanding of conducting study data readout activities, including data cleaning, data reputed company lock, data extract, producing outputs of data
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
• Serving as a contributing author to scientific publications and data presentations at scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

reputed company

Company H1B Sponsorship