**Senior Clinical Scientist I**
**Therapeutic Areas: Oncology & Immunology**
**Description of Services**
+ May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.
+ As lead, will be responsible for the following:
+ Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
+ Responsible for trial design and endpoint development in collaboration with CD
+ Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
+ Sets up/supports SAC, DMC, adjudication committees
+ Protocols/amendments – collaborates with medical writer, participates in governance committee review
+ Authors protocol clarification letters
+ Contributor to study specific documents (e.g., SMP)
+ Reviews/updates informed consent