We are a fast-paced, innovative, forward-thinking, and highly collaborative culture of scientists, technologists, R&D and other professionals that focus on therapies for small tumors including breast, gastric, ovarian, pancreatic, gall bladder and lung cancer. Triumvira has developed a proprietary T-cell Antigen Coupler (TAC) therapies that uniquely help T-cells recognize and eliminate tumor cells. We are currently in Phase I/II clinical trials and are excited to advance our pipeline so that we can improve patient lives.
This position is REMOTE and can generally be done anywhere within the United States. Candidates must be legally authorized to work in the USA for any employer without sponsorship.
Job Duties & Responsibilities
- Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols, ICFs and related documents.
- In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations, biostats and data management, contributes to the development of the plan to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization
- Collaborate within Development on the review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution. Conduct literature reviews as needed for the interpretation of study data and development of next steps.
- Works closely with the medical monitor to assure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
- Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
- Translational medicine: Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support stratification biomarkers.
- In conjunction with the Team Leader/Clinical Leader/CMO, develop presentations and communicates study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Serve as clinical science representative on cross-function teams as assigned.
Qualifications
- Advanced Clinical or Science degree e.g. Pharm D., MD, or PhD in a clinical discipline
- 5+ years in of clinical research experience, planning executing, reporting and publishing studies within bio/pharma
Work-related Skills & Experience
- Experience and knowledge of the medical aspects of GCP, ICH, FDA and other relevant guidelines and regulations
- Thorough understanding of the drug development process from pre-IND through registration and post-registration required
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy
- Successful track record for the ability to interpret, analyze, and present clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy
- Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols
- Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audiences
This role may require up to 20% travel domestically within the United States.
NOTICE TO AGENCIES: We do not accept unsolicited resumes or biographies from agencies. Triumvira is not open to Recruiting/Staffing agency support at this time. Our in-house recruiting team manages all employment opportunities. Please do not contact Triumvira employees directly. If you would like to be considered in future years as a vendor partner, submit your company overview to Human Resources.