VP, Translational Medicine
We are seeking a VP of Translational Medicine, who will be responsible for leading efforts involved in the discovery, development, technology transfer, and clinical application of biomarkers for use in the clinical development of UNITY molecules. This effort will involve biomarkers that will be used for disease assessment measures for patient stratification, target engagement markers, and disease progression and/ or treatment response biomarkers. The VP of Translational Medicine will sit at the intersection between discovery and clinical sciences and will be expected to work closely with researchers from both areas. The VP will also be responsible for establishing and maintaining relationships with external partners, collaborators, and vendors
This role requires an individual who can see the larger environment for which biomarkers will be applied while also managing details across a wide variety of fronts. The ideal candidate must have superior scientific, project stewardship, organizational and communication skills, possess strong leadership abilities, and have the ability to engage stakeholders at all levels. He or she must thrive in a fast-moving and dynamic environment and be able to maintain calm under pressure. Finally, he or she must be genuinely motivated by UNITY’s mission to bring pharmaceutical solutions for diseases of aging to patients who are most likely to benefit from our medicines.
- Responsible for early patient selection initiatives and their transition from discovery to early clinical programs
- Maintaining a mindset for future companion diagnostic programs, including providing expertise in discovery and development of clinical trial assays or IVD assays in multiple testing platforms
- Interfacing with research and clinical scientists to ensure seamless transition of patient selection strategies beyond Ph1, including working closely with translational scientists around the world
- Responsible for managing laboratory research and contract research organizations to design, develop and execute biomarker reagents and assays to deploy in Ph1/2 clinical trials.
- In collaboration with research and development scientists, responsible for creating and implementing biomarker plans including:
- Assisting in the development and/or identification of assays to use in clinical trials, management of execution of correlative science assays and data evaluation.
- Developing clinical trial protocols with determination of time points and tissues to be collected.
- Collaborate with clinical operations for identification of specialty laboratories, assay platforms and sample processing.
- Working with external collaborators to source patient samples, design and execute collaborative biomarker and analysis plan
- Other key activities will also include working closely with clinical investigators, identifying opportunities for translational medicine projects, delivering high quality presentations and acting as an internal resource.
- MD and/ or PhD with a preference for those trained in Clinical Pathology and with experience running clinical laboratories with a record in biomarker/ translational research with 10-12+ years experience. Ideal candidate would have experience in a Pharma Translational Science/ Medicine setting or in a major diagnostic company setting and would have strong technical knowledge and experience in multiple platforms and assays as lead development scientist or as project leader
- History working in x-omics platforms for assay discovery, optimization, assay configuration
- Strong understanding of regulatory approaches for use of biomarkers in drug development and in companion diagnostic registration paths across the world, including expecting requirements for analytic and clinical qualification and validation of assays
- Knowledge of third party assay transfer and IP licensing as they relate to in vitro diagnostics
- Expertise in the integration of preclinical research and clinical drug development
- Experience in setting priorities, directing projects and implementing complex strategies
- Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines
- Able to communicate in both written and verbal format complex and detailed information in a manner that enhances understanding and ensures that the recipient will be able to apply the information presented.
Please send a resume and cover letter to email@example.com.