Director, Clinical Research Scientist-

In collaboration with a therapeutic area VP of Clinical Development, the Clinical Research Scientist (CRS) will contribute to the design, conduct, analysis, and reporting of clinical trials. The CRS will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery to supporting the registration and commercialization of a product.

Key Responsibilities: 

• Contribute to the review, interpretation, and communication of scientific data pertaining to the efficacy and safety of compounds in the development
• Effectively collaborate with the VP of clinical development, the clinical trial manager, and the clinical operations manager on all aspects of clinical study development from start to finish
• Attend congresses and review literature to develop and augment expertise in their specific therapeutic area
• Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles, and draft labels.
• Review the competitive landscape and help identify and evaluate business development opportunities
• Have responsibility for providing focused scientific and clinical study support from start-up to clinical study report (CSR) and publications.
• Participate in the scientific education of internal and external stakeholders on the pre-clinical (e.g., mechanism of action, animal models) and clinical (e.g., epidemiology, diagnosis, treatment) data relevant to the program
• Engage opinion leader interactions to build pipeline awareness and foster research collaborations
• Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents
• Contribute to the creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct
• Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage assets
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings

Qualifications:

• Bachelor’s degree in the sciences; advanced degree (e.g., MS, Ph.D.) preferred
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred. (5 years of experience as a CRS preferred)
• Ability to provide input and direction to clinical research with appropriate supervision
• Strong desire to collaborate in a cross-functional setting
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the design of study protocols