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Clinical Scientist

The individual will participate in all aspects of clinical research and development, including participation of clinical and regulatory document preparation, clinical data review, literature review, preparation of presentation materials. The individual will work closely with other functional groups within OncoC4 and outside CROs. The position will report to the VP, Clinical Development, and interact closely with the senior leadership and external experts to ensure the successful execution of clinical development programs.

 

Responsibilities: ​

  • Work closely with other function groups, such as Clinical Operations, Drug Safety, and Regulatory Affairs, and apply your expertise and leadership skills to contribute to and develop of clinical protocols, amendments, study reports, safety documents, and regulatory documents.
  • Conduct literature search and solicit input from advisors to support clinical research concept development and specific research topics.
  • Manage the interaction with external consultants and provide support in the design, interpretation, and communication of clinical trials
  • Contribute to the preparation of clinical components in the regulatory documents (INDs, NDAs, and IBs) as needed.
  • Support in-house program management staff in assigned clinical programs.

Experience Required:

  • PharmD/Ph.D. or equivalent in biomedical sciences.
  • 2+ years of industry experience in clinical development, drug safety or medical affairs.
  • Background in immunology and/or oncology preferred.
  • Excellent verbal and written communication skills and experience of writing and reviewing clinical trial protocols, clinical study reports, and regulatory documents such as INDs, IBs, NDAs or BLAs.
  • Applicants must be authorized to work in the U.S.

 

Please send CV and any inquires to hschiltz@oncoc4.com and hychou@oncoc4.com.