Principal Clinical Scientist

Biogen Idec Cambridge, MA
Job Description

Stays current on internal/external trends as it relates to their therapeutic area; collaborates with internal/external stakeholders such as clinical investigators, operations, legal and regulatory in order to support the clinical development group. When needed they will provide input into budget/resourcing requirements in order to execute on the clinical development plan.

Authors clinical documents including but not limited to: clinical protocols, brochures, briefing documents, and other regulatory filings. Will be responsible for research, protocol writing, and case detail reporting. Responsible for ensuring clinical site and investigator training readiness is complete and ensuring those key job responsibilities are carried out in a consistent manner.

In partnership with the medical team, will help lead the development of clinical trial designs and protocol development for all phases of testing. Activities can include conducting clinical studies, preparation of meeting materials, communication plans, safety and medical monitoring, and preparation of reports.

Interacts with internal and external stakeholders (study sites, vendors, committees etc.) in support of clinical trial objectives; responds to or triage questions and escalates as appropriate.

Qualifications

10+ years of academic experience in/or clinical design experience