Clinical Research Scientist

Location
San Diego
Posted
Jun 29, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Summary

The Clinical Research Scientist plays a pivotal role to ensure the highest scientific quality and efficient achievement of project goals within the Triphase Development portfolio.  The incumbent will lead the tactical efforts for early clinical development projects from a clinical science perspective, including clinical study and biomarker data analysis and presentation, and provide input into IND and other regulatory submissions, clinical study protocols, amendments, and reports, and peer-reviewed publications.  The candidate will work collaboratively with Clinical Operations Lead, Clinical Trial Managers, and Director of Translational Science, as well as cross-functional Development Project Team members, to promote critical thinking in the design, execution, and interpretation of early clinical development activities, including incorporation of pharmacodynamic and pharmacokinetic endpoints into clinical designs.  Additionally, the incumbent must be able to effectively engage with key external stakeholders, including clinical trial investigators and site personnel. Reporting to the Vice President of Development, the incumbent will be responsible for keeping a current and comprehensive knowledge base of the disease areas and therapeutic landscape to support one or more clinical programs of varying complexity.

Roles & Responsibilities:

  • Analyzes, reviews, reconciles, and presents clinical data for early development studies
  • Represents Clinical Science in cross functional team meetings, including preparation and presentation of ad hoc clinical and biomarker data analyses
  • Effectively engages with internal and external technical/scientific experts to define, revise and progress translational/biomarker plans, including management of contract research activities, timelines and budgets
  • Coordinates with clinical operations personnel (i.e. study managers, CRAs), data management, biostats, and drug safety manager/physician in the review, querying and reconciliation of clinical data both in real-time and prior to database extraction
  • Contributes to the authorship and critical review of clinical study protocols and amendments, consent forms, case report forms, clinical study reports, and other clinical study documents
  • Contributes to the early clinical development strategy for development candidates, and to the nonclinical development strategy for preclinical programs assets as appropriate
  • Authors and reviews project documents including IND/CTA and other regulatory submissions
  • Assists as needed in preparation and presentation of meeting content for external advisory board and investigator meetings, including preparation of abstracts, posters, oral presentations and manuscripts for the purposes of peer-review and reporting of results from early development clinical trials at various external meetings (eg. ASH, ASCO, EHA, ESMO)
  • Contributes to the technical support for the clinical study managers, research associates and study site personnel in the day-to-day conduct of clinical studies
  • Attends professional meetings and congresses as relevant that allow for educational advancement or to improve/promote clinical development best practices

Qualification & Education Requirements:

  • Advanced degree(s) in relevant field: MD, MD/PhD, or PhD with a concentration in the life sciences, with academic and/or industry clinical science experience, and
  • 4-7 years of relevant experience in hematological oncology disease indications

 

 

Preferred Skills:

  • Clinical science experience including (but not limited to): compilation of INDs/CTAs and other regulatory submissions; Phase 1 to proof-of-concept clinical study protocol development, case report form design, clinical study report writing; biomarker development/applications; clinical data analysis, interpretation, review and reconciliation; effective investigator and site communications; and abstract/peer-reviewed publication development
  • Prior experience in regulatory affairs, drug safety, medical writing, clinical pharmacokinetics, preclinical toxicology, project team leadership, and/or CMC would be beneficial
  • Strong planning, organizational, written and oral communication skills
  • Proficiency in the use of industry-standard software including at least one clinical database platform
  • Ability to inspire a positive work environment and help champion quality, innovation and teamwork

Qualified candidates are invited to submit their resumes and cover letters to: careers@triphaseco.com