Totus Medicines, an innovative therapeutic drug discovery biotech, is just emerging from stealth. With a $40M Series A, Totus is poised to revolutionize drug discovery. For the first time, Totus is enabling genome-scale drug discovery to allow the identification of precision medicines for hard-to-drug targets. At its core, Totus is a chemical biology company. Totus’ novel proprietary platform allows screening at a rate more than 100,000 times faster than competitive technologies. Totus has pioneered the development of selective medicines for patients with genetically defined cancers and plans for its first program to enter Phase I by end of 2022. Totus also plans to expand their platform to create therapeutics targeted at neurodegeneration, infectious diseases, and others. We are searching for talented, passionate, high-energy candidates to join our growing team.
The Director of Translation Medicine Research will provide leadership and implementation of biomarker discovery strategy for successful translation and development of our oncology therapeutic pipeline molecules from the pre-clinical proof of concept stage in Research and Early Development for first-in human trials. This individual will bring deep scientific experience in Oncology discovery and companion diagnostic development to guide, shape and execute the strategic vision for indication selection for pipeline molecules and, in partnership with the research group, discover new efficacy and/or safety biomarkers for such molecules. This position will be part of the Clinical Development team initially reporting directly to our CMO.
In this role you will:
- Drive biomarker discovery and strategy for the pipeline molecules
- Drive the companion diagnostic development for the pipeline molecules if applicable. Familiarity with the regulatory requirements is a must.
- Serve as key interface and manage all outsourced activities and vendors relations for human PK/PD/biomarker sample management, sample analysis, etc., or drive the collaborations with academic institutions when applicable
- Interface with the research group to integrate discovery and pre-clinical development activities to support drug development efforts
- Build, drive and guide the team towards managing project budgets and timelines to achieve targets
- Proficient in implementing new technologies for biomarker discovery and companion diagnostic development.
- Engage with key stakeholders including clinicians, researchers and patient groups to better understand disease burden, unmet needs, meaningful endpoints, acceptable and feasible clinical development strategies, pathways to efficient development of a companion diagnostic, as well as opportunities to partner with other companies towards the shared goal of finding better treatment
- Ensure that translational medicine contributions to Investigational New Drug (IND) submissions are planned and executed in a timely manner.
- Liaise with cross-functional teams and serve as the primary Translational Medicine interface to peers in Research, CMC, Regulatory, Clinical Development, Clinical Operations, Project Management, Business Development groups with a focus on biomarker planning, platform issues including vector design, delivery, pre-clinical studies and alignment with clinical trial design.
- Maintains scientific awareness regarding advances in indications of interest, regulatory awareness regarding new guidance and rules, and industry awareness regarding trends and competition through literature, conferences and stakeholder interactions.
- Other related job duties as assigned.
Requirements:
- P.h.D with strong background in oncology is essential and 10+ years of direct experience in the therapeutic development space
- Industry expertise in the areas of translational medicine or biomarker biology and proven track record of contributing to the development of a companion diagnostic.
- Strong understanding of translational medicine, drug development and regulatory issues is required
- Proven track record of ability to identify / implement cutting edge methodologies
- Demonstrated expertise managing/developing staff and building infrastructure with department processes, systems and Standard Operating Procedures (SOPs).
- Develops and manages cross-functional program operation plans, cost estimates, budget management and communicates with senior management with status, alerts, and clinical program milestones as they fit into overall corporate objectives
- Independently motivated, detail oriented and good problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Proven ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Must have an ability to think strategically and communicate clearly to set and guide the translational sciences strategy
What We Offer
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A knowledgeable, high-achieving, experienced and fun team
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A diverse work atmosphere
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The chance to be part of a growing startup and the next success story
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The opportunity to shape our company culture
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Constant learning and dynamic challenges to help you grow and be the best version of yourself