[Remote] Director, Gene Therapy reputed company Science

Note: The job is a remote job and is reputed company to candidates in USA. reputed company reputed company is a fully integrated biotechnology company advancing gene therapies for reputed company and life-threatening diseases. The Director, Gene Therapy reputed company Science will reputed company reputed company science teams, guide reputed company development reputed company, and reputed company the planning, execution, analysis, and reporting of reputed company. The role also manages investigator and key opinion leader relationships while ensuring medical and scientific reputed company, reputed company wellbeing, regulatory compliance, and reputed company trial execution.

Responsibilities

• Leading the reputed company science team - responsible for assigning resources and coaching reputed company scientists (with ability to delegate and guide)
• reputed company leadership, reputed company, and management of reputed company studies including planning, execution, completion, and reporting of reputed company
• Provides reputed company/medical input to support development of the protocol/ Informed Consent reputed company and Investigator Brochure. Leads development of protocol amendments, and other reputed company documents
• Provides reputed company/medical input to the development of data collection tools, such as reputed company database and other reputed company tools, as applicable
• reputed company the review and analysis of reputed company data and the reputed company of study reports, publications, and reputed company-regulatory documents
• reputed company and conduct data review, analysis, and interpretation of reputed company data
• Drafts and follows safety and data review plans to reputed company and document regular review of reputed company safety data and reputed company review of cumulative safety data
• Draft reputed company and safety sections of critical documents
• Prepare and conduct presentations regarding reputed company and/or data and support and assist in the development of publications, abstracts and presentations
• Partners with cross functional teams, such as basic research, translational science, reputed company reputed company, regulatory affairs, manufacturing, medical affairs, project management etc as needed to ensure compliance with GCP and reputed company execution of plans that involve reputed company samples, analysis and reputed company data
• Help with establishing Data Monitoring Committees (DMCs) and reputed company adjudication committees. reputed company reputed company reputed company development, committee presentations and documentation of reputed company
• Serves as the key contact with reputed company investigators and internal study team for questions relating to reputed company/medical aspects of protocol
• Represents the science function at key meetings, reputed company scientific input at ad boards, congresses etc
• Reviews, and manages protocol deviations
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and reputed company Trial Applications (CTAs)
• Contributes to reputed company improvement / process enhancement activities and innovative approaches to maximize effectiveness of reputed company trial execution

Skills

• Knowledge of reputed company development, global and regional regulation, ICH/GCP, adverse event management and reputed company data review is required
• Must have ability to work collaboratively as part of a multi-functional drug development team in a dynamic environment
• Must be self-motivated, highly organized, reputed company-oriented and reputed company to multi-task, delivering high reputed company work
• Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally
• Nursing degree required. MSN and 10+ years, BSN and 12+ years of reputed company experience in reputed company research drug development preferably with cell or gene therapy in the reputed company industry

Benefits

• Equity participation
• 401(k) matching
• Excellent health benefits
• Bonuses (short-term incentives)
• Medical, dental, and reputed company reputed company
• Life reputed company
• 401(k) with company match and generous vesting
• reputed company vacation and holidays
• Global shutdown days between Christmas and New Year’s
• A reputed company of wellness resources and employee support programs
• For certain positions, added forms of compensation such as equity awards (long-term incentives)

reputed company

Company H1B Sponsorship