Senior Clinical Science Manager

Role Summary

Senior Clinical Science Manager supporting design, planning and development of clinical narratives and related documents in oncology clinical evaluation studies with a focus on solid tumors. Assists in preparation and authoring of clinical development documents, narratives, SOPs, work process documents, study synopses, and protocols; summarizes study results for narratives and publications; supports project teams with process flow documents and progress updates.

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 as necessary to support Clinical Study Reports.
• Assist in writing and/or reviewing product-specific abstracts, publications, and support the development of presentations for scientific meetings.
• Provide proactive feedback on emerging clinical and competitive trends.
• Deliver high-quality scientific presentations on investigational agents to physicians and other key external customers.

Qualifications

• Required/Preferred: BS/BA in related field with minimum of 9 years of related experience; or MS/MA with minimum of 7 years; or PharmD/PhD with minimum of 2 years; or equivalent combination of education and experience.
• Two to five years of clinical development experience in biotechnology or pharmaceutical industry; public presentation experience and education program development preferred.

Knowledge/Skills

• General knowledge of clinical trial implementation and drug development process.
• Ability to identify and implement methods and procedures to achieve high-quality results.
• Ability to perform a variety of complex tasks with creativity and latitude.
• Understanding of technical principles, theories, concepts, and techniques.
• Strong analytical and business communication skills.
• Experience in preparation of clinical or safety-based clinical narratives.
• Highly organized and able to work under tight timelines.
• Good public speaking and presentation skills; good technical writing skills.

Education

• BS/BA, MS/MA, PharmD or PhD in related field with relevant experience as described in Qualifications.

Additional Requirements

• Travel: 10-25% travel requirement.