Clinical Scientist (#2725)

Clinical Scientist

Job Description:

The Clinical Scientist will provide scientific, pharmacologic and/or medical input into publications, trial designs and protocols across all stages of clinical development and support regulatory submissions worldwide.

This individual will collaborate across multiple functional areas including clinical development, translational research, regulatory and clinical operations to develop and implement protocols, publications, presentations and submissions that advance the clinical development plans for assigned programs.

This role will work with cross-functional and global collaborations to integrate broad medical and scientific input into development programs and clinical development plans for assigned programs and molecules. Depending on corporate/programmatic needs and individual aptitudes, the role may primarily focus on Safety, Clinical or Scientific Research aspects of assigned programs.

Responsibilities in collaboration with the project physician will include, but are not limited to:

• Project work and responsibilities as appropriate, including:
  • a) Prepare and/or assist with preparation of key documents e.g., Investigator Brochures, regulatory submission documents, internal and external presentations
  • b) Prepare synopses and protocols (writing, reviewing, amending and cross-functional facilitation as appropriate) and Informed Consent Forms;
  • c) Participate in clinical development plans for assigned compounds;
  • d) Review safety, primary efficacy variables, and laboratory data
  • e) Contribute and lead study specific biomarker plans
• Support Clinical Directors /Medical Director in scientific leadership and investigator initiatives
• Support/lead clinical biomarker plans and execution
• Review scientific literature and prepare presentations, regulatory submission documents, etc.
• Analyze and interpret clinical and scientific data from the company and from the literature to support the research programs. Develop and investigate hypothesis that help advance the research programs.
• Collaborate with and support interactions with clinical sites as needed
• Support clinical operations in the planning of investigator meetings and execution of clinical plans
• Develop and deliver study specific training presentations as needed
• Review clinical data including: safety, primary efficacy variables, and laboratory data
• Participate in reviewing and testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems. Monitor data during the course of the study. Identify potential clinical data issues and provide senior team members with feedback to remediate issues
• Assist in the review TFLs and SAS outputs of cleaned data at test runs and database close
• Contribute to the development of clinical study reports
• Review of SOPs, training guidance, and templates as needed.

Skills/Knowledge Required:

• A Bachelor’s degree with at least 7 years’ clinical research and/or clinical translational experience in the pharmaceutical industry or CRO (MS with 5+ years or a Ph.D. with >2 years relevant experience)
• Oncology experience required
• Working knowledge of clinical trial design and execution
• Experience in protocol development and regulatory submissions
• Adherence to the highest standards for trial conduct, patient safety and data integrity
• Medical/technical writing and basic statistics expertise preferred
• Working knowledge of GCP, ICH Guidelines and standard medical terminology
• Experienced with Microsoft Office applications (e.g., Excel, Powerpoint)
• Familiar with Electronic data capture (EDC) systems (i.e, iMedidata, TrialMaster or InForm)
• Proficiency in literature searches and standard data mining, interpretation and presentation
• Ability to assimilate technical and scientific information accurately and quickly
• Able to work with cross-functional teams and meet deadlines in a fast-paced work environment
• Outstanding written and verbal communication skills; and
• Meticulous and well-organized.
• Basic sequencing data analysis is a plus