Clinical Scientist, Clinical Development

COMPANY:

Established subsidiary of a global biologics organization focusing on development in oncology and rare disease.

LOCATION:

Cambridge, MA

TITLE:

Clinical Scientist, Clinical Development - Full-time, Permanent

ROLE RESPONSIBILITIES:

The Clinical Scientist will ensure delivery of quality study strategy and design and contribute as appropriate to the end to end delivery of clinical development activities. This individual will also implement new business processes and strategies and identify issues ad propose strategies to manage implications and risks on clinical study/Clinical Development Plan. Other responsibilities include:

• Accountability for Phase 1 study design, including clinical pharmacology study designs supporting the CPD
• Contributes to all regulatory reporting requirements
• Participates in eCRF development
• Presents the scientific rationale and study design at Investigator Meetings
• Delivers end-of-study reports and publication/presentation of results

CANDIDATE REQUIREMENTS:

• Relevant, scientific degree and a minimum 5+ years of industry or relevant clinical experience. Advanced degree (i.e. MS, PhD, PharmD) preferred
• Oncology or immune-oncology experience
• Broad understanding of the pharmaceutical industry and the clinical development process
• Clinical training and/or applicable clinical research experience; understanding of running clinical trial from concept study idea to publication
• Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.