Only local San Francisco Bay Area candidates!
Direct W2 employees only!
Seeking a candidate with a bachelor s degree and preferably an advanced clinical/science degree (e.g. PharmD, PhD, MPH) with at least 4 years of industry experience to work on a late stage molecule for ulcerative colitis and Crohn s disease. Multiple ongoing Phase 3 studies with data readouts for ulcerative colitis next year.
Cross-Functional Team Membership
Clinical Development Plan Implementation
o Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
o Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
o Responds to questions from other internal and external parties regarding assigned studies and programs
o Helps coordinate the successful completion of documents with other groups
o Collaborates with clinical science, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc.
o Works with clinical science, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
o Assists in responding to health authority inquiries
o Works closely with clinical science, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting
o Supports clinical science, regulatory and other internal partners/stakeholders with completion of clinical study reports
o Completes other special projects, as and when assigned, or otherwise requested
o Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as preferred, or as a plus, all points listed below are considered minimum requirements.
QUALIFICATIONS & EXPERIENCE:
Burlingame, CA, 94010Contact