Principal Scientist, Clinical Research Job
Job Description Job Attributes+
The Principal Scientist, Clinical Research will be an essential contributor to cross-functional project teams responsible for product development providing strategic scientific and clinical guidance for the development and execution of clinical programs. The Clinical Research Scientist will be responsible for various aspects of clinical program development and implementation including, but not limited to, authoring relevant clinical documents for regulatory submissions, and providing oversight and implementation of clinical programs.
What Clinical Research Regulatory Sciences contributes to Cardinal Health
Research is responsible for the development of new and improved products through initiating, designing, developing and executing research and product development projects.
A component of the drug development process which occurs in sequential phases including: discovery, pre-clinical research, filing an Investigational New Drug (IND) application, Phase I-IIIb study conduct and monitoring, verification of research data, preparation of clinical study reports, integration of efficacy and safety clinical data for submission of a New Drug Application (NDA) or Post Marketing Approval (PMA) to the Food and Drug Administration (FDA) and/or other global regulatory agencies, and the conduct of formalized post-marketing research (Phase IV).
The Principal Scientist, Clinical Research will be an essential contributor to cross-functional project teams responsible for product development providing strategic scientific and clinical guidance for the development and execution of clinical programs. The Clinical Research Scientist will be responsible for authoring clinical sections of and relevant clinical documents for regulatory submissions including the design and authorship of study protocols. The Clinical Research Scientist will be responsible for the design, authorship, planning and implementation of study protocols for both investigational and post-approval products and support clinical development programs by reviewing, evaluating and interpreting scientific and medical data and reporting clinical study results in a manner consistent clinical development strategy, industry standards and applicable regulations.
Qualifications10-12+ years relevant clinical, scientific and/or drug development experience preferredBS, MS, PhD in health science field preferred; PharmD, MD or other relevant advanced degree in health science field preferredStrong Project Management and Medical Writing skills, specifically experience with clinical sections of IND, NDA, clinical protocols, and/or investigator brochuresExperience with clinical research and clinical operationsStrong understanding of ICH GCP, as well as general knowledge of industry practices and standards
Anticipated salary range: $108,600 - $167,000 base
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.