Triumvira is a multi-national, clinical stage biotechnology company with headquarters in Austin, TX and laboratory facility in Hamilton, Ontario.
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.
Candidates must be authorized to work in the USA without visa sponsorship, as Triumvira does not provide visa support.
The Medical Director will be part of the Clinical Development and Operations Groups which are responsible for driving clinical development strategy and execution.
This role will have direct responsibility for the design, execution, oversight and analyses of clinical trials of Oncology TAC-T Cell Therapy. The Medical Director will also work closely with the technical and R&D/Translational Medicine teams to incorporate the appropriate biomarker studies into the protocol and to correlate clinical and translational findings to drive optimal clinical development. In addition, this individual will be providing medical and scientific expertise to cross-functional colleagues and play a critical role partnering with the Chief Medical Officer (CMO) in defining the clinical strategy for the company.
- Medical Monitoring
- Medical review of trial data, including reviewing eligibility data
- Clinical site interactions including addressing medical questions and providing site education (including safety management) and assessment of key safety-related serious adverse events and approving safety narratives
- Drafting of clinical protocols, along with medical writing & colleagues from Clinical Operations and providing the medical strategic oversight of protocol development including study design, targeted patient populations, eligibility criteria and defining safety risks & mitigation strategies
- Fulfilling GCP and compliance obligations for clinical conduct and maintaining all required training
- Contributing to the Clinical Strategy and Clinical Development Plans for the company’s asset(s)
- Providing oversight and medical accountability for the company’s clinical trials
- Identifying/ building relationships with principal investigators and KOLs on the treatment modality, indication and novel clinical trial designs and biomedical statistical analyses
- Supporting the executional delivery of clinical studies (e.g., site activation, status of enrollment, adjudication for protocol violations, medical validation/ data clean-up and as the medical resource for the site staff)
- Interacting with Health Authorities & IRBs/ECs as the Clinical Program Lead
- Drafting and authoring clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filing of the study in partnership with colleagues in clinical operations.
- Staying current on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to strategy or clinical development plan if needed
- Maintaining a clinical and scientific reputation in the modalities and diseases pertinent to Triumvira
Education & Certifications
MD is required (or a US-equivalent)
Sub-specialty training in Medical Oncology and/or Hematology
Work-related Skills & Experience
- 5 or more years of Biotech/Pharma industry experience in Oncology Clinical Trial development and execution
- Experience in the drug development process, delivering and executing on effective clinical trial plans and protocols
- Leadership and mentorship skills with a hands-on (working leader) approach is required
- Proven ability to lead teams, especially in a remote/virtual environment and cross functionally is very important
- Ability to travel up to 30% (domestic and international)
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.