We are seeking a Director/Senior Director, Translational Research to build and operationalize clinical biomarker strategies to support clinical development. Reporting to the Executive Director, Research, the successful candidate will bring deep scientific and therapeutic area experience with regards to biomarkers, early clinical development, interpret biomarker results that help with effective project level decision making, and communicate effectively with senior management and teams in a highly matrixed environment. As a member of our translational research team, you will be a vital part of shaping our translational strategy and vision.
This position will work across research and development groups, collaborating with medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of clinical development strategy, and agreement on biomarker needs. The candidate will be a key part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned program(s).
Responsibilities (includes but not limited to):
- Primary accountability for developing indication selection and translational biomarker strategies in collaboration with Research and Clinical Teams that assess proof of target engagement, and/or pharmacodynamics activity, establish early signs of efficacy, enabling proof of concept studies, and understanding disease progression
- Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response
- Serve as a key strategic resource for exploratory biology, experimental medicine, and clinical science teams – providing key biological validation by leveraging insight gained from patient-derived functional, genetic, and biochemical biomarkers
- Develop and coordinate patient selection, biomarker and companion diagnostic strategies for projects across Kiniksa’s growing portfolio
- Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents as appropriate. Supports scientific input and review of all translational research aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, regulatory submissions and responses to any regulatory questions, etc.
- Provide domain area expertise to discovery and development project teams and further enhance Kiniksa’s scientific reputation through high impact publications and presentations
- Function as a scientific and business thought-leader inside and outside of the company and a key link to external community
- Support Business Development efforts by supporting potential out-licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with FDA, as required
- Works closely with discovery stakeholders to understand evolving project portfolio, identify knowledge gaps related to target diseases, and prioritize resources needed for specific assets
- Partners with discovery colleagues on biomarker-related internal studies, consortium work, or academic collaborations as needed
- Consults with project teams on biomarker discovery, pre-strategic assessment of indications for clinical samples profiling and understanding of mechanism or disease related biology
- Collaborates with research and clinical colleagues to develop scientifically rigorous translational and exploratory biomarker strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and generate an understanding of the variability in patient response
- Provide leadership and mentoring for scientists and research associates
- PhD in molecular/cell biology, biochemistry, or immunology with relevant post-doctoral training with 8+ years of pharmaceutical or biotechnology industry experience in biomarker discovery and companion diagnostics
- Strong interpersonal, influencing and collaboration skills to work in a team-oriented, matrix environment, and the ability to work through conflicts
- Ability to drive and influence projects from discovery through early clinical development with a focus on the identification of indications with biomarkers of response and/or resistance to therapy
- In depth experience in the discovery, validation and clinical implementation of innovative biomarkers and companion diagnostics
- Excellent management skills, including the ability to set high but reachable goals, define priorities, manage individual performance, and infuse the team with a sense of purpose and urgency
- Thorough understanding of clinical development and discovery research, and analytical and clinical validation of biomarker assays
- Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex genomic data sets emerging from clinical trials
- Excellent communication skills, ability to present the results in clear and concise manner.
- Passion for developing new therapies
- Must be able to work under pressure, meet tight deadlines, multi-task and be able to pivot in response to changing priorities while maintaining a positive and collaborative attitude