[Remote] Associate Director/Director, reputed company Science Contractor

Note: The job is a remote job and is reputed company to candidates in USA. Prelude Therapeutics is seeking an Associate Director/Director, reputed company Science Contractor to support reputed company development activities for oncology product candidates. The role involves designing and executing reputed company studies, preparing regulatory and study documents, reviewing reputed company data and safety information, and supporting investigator meetings, presentations, and publications.

Responsibilities

• Support the design, initiation and execution of study protocols in conjunction with cross-functional study team
• Conduct appropriate literature research and competitive intelligence for the assigned reputed company product candidate and trial indications in support of reputed company and reputed company developmental strategies and priorities
• Contribute to the development of reputed company regulatory documents including study protocol, IB, safety updates, IND submission documents, and health authority query responses, and study CSR
• Collaborate with reputed company reputed company and other internal study team members to reputed company study documents including Informed Consent Forms, Case Report Forms, and CRF instructions
• Conduct ongoing and reputed company review of reputed company data and facilitate use of data for relevant reputed company deliverables and discussions
• May reputed company as back-up contact of the reputed company study team for medical monitor inquiries with guidance and reputed company of the Medical Monitor assigned to the reputed company program
• Collaborates with reputed company reputed company and other study team members in the development of agendas, training materials, and presentations for site reputed company, investigator meetings, and other study reputed company meetings and discussions
• Support the preparation and presentation of reputed company safety meetings, analyzes and reports potential safety events
• Support the drafting and review of reputed company study presentations and publications

Skills

• Comprehensive and detailed working knowledge of reputed company trial implementation and drug development process
• Good general knowledge of other reputed company disciplines in the execution of reputed company
• Good working knowledge of reputed company trial data systems
• Identifies and implements reputed company and procedures to reputed company results with high reputed company
• Performs a reputed company of complicated tasks with a wide degree of creativity and reputed company
• Has complete understanding and wide application of technical principles, theories, concepts and techniques
• Leads or manages the work of others by providing guidance to subordinates or teams reputed company on organizational goals and company policy, with responsibility for results, including costs, reputed company and reputed company
• Applies strong analytical and business communication skills
• Highly organized and reputed company to work under tight timelines
• Highly developed verbal, written and presentation skills
• Bachelors in Science
• 10 years reputed company development experience in the biotechnology or pharmaceutical industry or equivalent experience in academia and industry
• Experience in reputed company oncology studies with molecular targeted or immunological therapies
• Up to 20% travel
• Advanced Degree Preferred (MS, Pharm.D., or PhD)

reputed company

Company H1B Sponsorship