Marengo Therapeutics is seeking a Senior Director, Translational Medicine to join us in this exciting phase as we move into the next chapter of bringing our science to cancer patients
Our Senior Director, Translational Medicine will be responsible for advancing research discoveries into novel therapies, discovering, and developing novel biomarkers and strategies to support clinical trials and derive new research directions and drug discovery insights from biomarker data collected from clinical trials.
The successful candidate will be responsible for the innovation, development and execution of biomarker and diagnostic strategies to contribute to preclinical and clinical development across a rich pipeline of investigational therapeutics through all phases in Marengo’s portfolio. The successful candidate will combine creativity and collaboration together with excellence in execution and delivery on the portfolio.
The successful candidate will work closely and collaborate with leaders/teams across Discovery, Immunology, and Clinical and Product Development organizations within Marengo to discover and develop impactful therapies that provide transformative benefit for patients. Translational medicine and biomarker development are integral to the drug development process across all stages. This position will report to the Chief Development Officer.
Responsibilities and Duties
- Work with key functional experts/teams to integrate genetics, genomics, immunology and other complex biological datasets early into the life cycle of Marengo’s pipeline programs, to develop clinically implementable biomarker strategies to support selection of the most optimal indication / patient population, assess pharmacodynamic effects and impact on disease pathways, , evaluate patient or disease factors that correlate with therapeutic response/resistance, and consider the potential/requirement for companion diagnostics (CDx)
- Work closely with program teams and other members of the development team to develop and implement fit-for-purpose biomarker strategies for Marengo’s clinical trials that balance the need to report quantitative pharmacology and scientific exploration. Such strategies include developing biomarker-based, robust decision-making framework, overseeing assay development, qualification and validation with Marengo scientists and contract research organizations, and contributing to clinical trial design, biomarker implementation, study assessments, sampling schedules, and analyses
- Proactively provide insight into novel ways to incorporate biomarkers into clinical designs while reducing complexity and patient burden, including insight into new clinical technologies that streamline or improve operational implementation of biomarkers into clinical trials.
- Collaborate with internal and external stakeholders to provide the Companion Diagnostic (CDx) strategies including engagement with regulatory agencies, Dx companies, and delivery of CDx plans, where required
- Partner with Marengo’s teams and external stakeholders to evaluate state-of-the-art technologies for the assessment of biomarkers (e.g., pharmacodynamic or disease pathway) from clinical and preclinical samples to support Marengo’s portfolio
- Derive understanding of cancer pathway interactions, feedback mechanisms, and features of tumor microenvironment in clinical samples to guide rational drug combinations
- Author, coordinate and prepare the biomarker and translational content of protocols, investigator brochures, study reports, including authoring, reviewing or supporting regulatory filings, and making or contributing to presentations and publications where appropriate.
- Partner collaboratively across Marengo teams and foster a culture of scientific excellence, innovation, and inclusion
- Stay current with scientific and translational literature and investigate, create, and develop novel methods and technologies for project advancement
- Provide high-level updates and advice to senior management, including evaluation and interpretation of biomarker study data and their potential impact on Marengo’s programs and clinical/regulatory strategy
Qualifications and Skills
- Advanced degree (Ph.D., M.D., M.D./Ph.D., Pharm.D.), with focus on oncology and 5-8 years experience in Oncology translational and clinical development. Immuno-oncology experience highly preferable.
- A sophisticated understanding of cancer biology, cancer multi-omics assessments and immuno-oncology, with a track record of focus on translational research and clinical biospecimen analysis in early-phase clinical trials
- A deep understanding of the role of translational science/medicine and clinical biomarkers in drug development and a working knowledge of all functional areas of drug development including biology, regulatory processes, and clinical development
- Expertise in biomarker discovery and development and translational science (designing, implementing, executing, and interpreting studies of cancer biomarkers in clinical trials, including biomarker assay/platform development, validation, and clinical application) as demonstrated by publications, regulatory submissions and/or national or international presentations
- A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a “big picture” innovator who can recognize possibilities
- Direct experience or familiarity with state-of-the-art technologies applicable to cancer biomarker or immune response analysis such as next-generation sequencing, immunohistochemistry, immunofluorescence, flow cytometry, in situ hybridization, gene expression profiling, and digital image analysis
- Experience contributing to multiple projects in a highly collaborative, multi-disciplinary team setting