This position is responsible for working with the physicians and cross functions within Clinical Development to provide clinical research support for programs as assigned by phase.

Responsibilities

In collaboration with cross functional teams performs the following:

• Develops protocols and informed consent documents for clinical studies
• Analyzes and works with clinical data
• Drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, and other documents for FDA/EMA submissions
• Contributes actively in the CSR preparation and finalization
• Monitors, & reviews along with the medical monitor safety and efficacy data in ongoing studies; monitors GCP compliance with help of clinical operations and CRO
• Contributes to the development of CRFs
• Answers along with the medical monitor patient eligibility questions from CRO and site and questions from IRB/EC and health authorities
• May have a leadership role in the matrix teams for assigned compounds
• Develops and maintains relationships with appropriate KOLs, investigators, cooperative groups, and patient advocacies. Serves as first point of contact for medical questions from sites
• Assists and/or writes with clinical abstracts, assists and/or presents data at scientific meetings, SIVs; conducts protocol training
• Participates with clinical operations in the CRO/vendor selection and bidding
• Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development and regulatory requirements
• Acts as a clinical representative in variety of cross-functional teams

Qualifications

• Degree in scientific/life-sciences/clinical/nursing field. M.S., Ph.D. preferred
• Prior hematology or oncology drug development experience is highly desired
• Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment
• Excellent written and oral communication skills
• Strong analytical ability