Senior Clinical Science Manager

Role Summary

Senior Clinical Science Manager responsible for supporting design, planning and development of clinical narratives and related documents in oncology clinical evaluation studies focusing on solid tumors; also assists in preparing and authoring clinical development documents, SOPs, work process documents, study synopses and protocols; summarizes study results for narratives and publications; supports process flow documents and provides progress updates for assigned clinical studies.

Responsibilities

• Collaborate with clinical teams for a specific product candidate, including design, preparation and initiation of clinical narratives and other trial-related documents in compliance with project plans, federal regulations, GCP and good medical practice.
• Conduct literature research for the assigned clinical product candidate.
• Work with the medical monitor to enable interaction with clinical sites and thought leaders in oncology to assist sites in efficient completion of clinical narratives and other documents to support clinical trials.
• Maintain clinical and technical writing expertise in Oncology; review scientific journals and attend key meetings as warranted.
• Collaborate with team members in clinical review and interpretation of study data to prepare reports for health authorities including regulatory filing documentation and study close-out reports.
• Prepare clinical patient-based narratives to support Clinical Study Reports.
• Assist in writing and/or reviewing product-specific abstracts and publications, and support development of presentations for scientific meetings.
• Provide feedback on emerging clinical and competitive trends.
• Deliver high quality scientific presentations on investigational agents to physicians and other external customers.

Qualifications

• Required: BS/BA in related field with a minimum of 9 years of related experience; or MS/MA with a minimum of 7 years; or PharmD/PhD with a minimum of 2 years; or equivalent combination of education and experience.
• Experience/The Ideal For Successful Entry Into Job: Two to five years of clinical development experience in biotech/pharma or academia, industry; experience in public presentation required; education program development preferred.

Skills

• General knowledge of clinical trial implementation and drug development process
• Ability to identify and implement methods and procedures to achieve high quality results
• Capable of handling complex tasks with creativity and initiative
• Understanding and application of technical principles, theories, concepts and techniques
• Strong analytical and business communication skills
• Past experience in preparation of clinical or safety-based clinical narratives
• Highly organized and able to work under tight timelines
• Public speaking and presentation skills
• Technical writing skills

Education

• BS/BA, or MS/MA, or PharmD/PhD in related field with corresponding years of experience as listed in Qualifications

Additional Requirements

• Travel: 10-25% travel requirement