My client is an Early Stage Connecticut Pharmaceutical company.

 Senior Clinical Scientist - Oncology

 Overview:

You will work with the Medical Director to design, implement and executive of Phase 1 to 3 clinical trials, for ultimate culmination in clinical study reports and NDA/MAA submissions.
Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, clinical trial professionals and key
opinion leaders.

Responsibilities include but are not limited to:
The Senior Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring

of clinical development programs. These programs include early proof of concept through registration studies in a variety of targets and may involve collaborations with corporate

development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This person must be interested in working in a

fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

Serve as the clinical science representative on global and regional clinical execution teams.

• Create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs,

Data Management, Study Monitoring and pre-Clinical Development.

• Lead the design, implementation, operations/study management, and interpretation of clinical trials.
• Lead the writing of protocols, Informed Consent Forms, clinical study reports and regulatory-related documents.

Job Qualifications:

• PhD, PharmD. or M.D.
  The ideal candidate will have 5 years of biopharma experience in an academic or industry setting
  and at least 2+ years’ medical/clinical scientist experience. At least 5 years’ clinical research
  experience preferred, particularly in drug development.
  Clinical trial expertise along with experience in oncology with drug development highly desirable.
  Must possess a strong background in clinical trials in an academic or industry setting.
  Extensive academic/industry experience in laboratory-based cancer research or clinical trials is
  preferred
• Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
  • Have a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes
  • Experience in filing and defending US INDs and/or NDAs and international equivalents preferred