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Principal Scientist, Clinical Research

in Remote Location

Principal Scientist, Clinical Research Job

Job Description Job Attributes+

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  • Job ID

    29bc700f-88f5-48e1-984c-a298f37def38

  • Req #

    20116902

  • Job Location

    Remote Location

  • Job Category

    Research

  • Job Type

    Regular

  • Schedule

    Full time

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.      

Responsibilities

Interact and work in close collaboration with cross-functional project teams (internal and external participants) to provide scientific and clinical guidance for the development and execution of clinical programs for both investigational and post-approval products.Author and/or contribute to the authorship of clinical sections of regulatory submissions (e.g., INDs, NDAs) and relevant clinical documents including, but not limited to, briefing documents, clinical study protocols and amendments, investigator brochures and annual reports.Act as a recognized clinical expert, both internally and externally, for assigned clinical programs.Participate in the review of statistical analysis plans, table, listing and figure design and CRF development.Participate in the review, evaluation, and interpretation of clinical study data.Author or contribute to the authorship of clinical study results in the format of clinical study reports, scientific presentations (abstracts, posters, slide decks) and/or manuscripts in a manner consistent with clinical development strategy, industry standards and applicable regulation.Provide oversight and implementation of clinical programs, overseeing and collaborating with third party vendors (e.g., CROs, medical directors, principal investigators, and other clinical and medical personnel).  

Qualifications

10-12+ 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

Bonus eligible: Yes
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

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.

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