Q32 Bio is advancing an innovative platform and integrated portfolio of immunomodulatory therapies. With our strategy of protein-based molecules we aim to deliver life-changing treatments for patients with a variety of diseases for whom inadequate options exist.
Our dynamic, industry-experienced team is growing. We are seeking a candidate to lead our human disease translational research activities. This is a highly collaborative and strategic leadership role including cross-functional collaboration with our research and clinical development teams.
The candidate should have a strong background in immunology/inflammation and desire to be part of an energetic, fast-paced company. The candidate will oversee translational activities supporting the clinical development of ADX-097, a tissue targeted complement regulator protein and ADX-914, an anti-IL-7R antibody. This will include developing approaches to support establishing proof of mechanism (POM) evaluation in the clinic, relevance of target biology to human disease, and biomarker development. This candidate will also work closely with research and clinical teams to prioritize disease indications for both the ADX-097 and ADX-914 programs. The role will require partnerships with scientists and clinicians in the company and with outside collaborators and CROs to develop capabilities that have the potential to directly impact clinical trial strategy and design, including patient stratification. These efforts will be integrated into the larger clinical development plans for our lead programs. Ideally, the candidate would be an internal thought leader in scientific and disease areas relevant to Q32 Bio programs.
- Develop program specific translational strategies that integrate preclinical research findings and enable proof of mechanism and proof of concept evaluation in early clinical trials
- Partner with the clinical development team in order to integrate a translational biomarker strategy into early clinical trial designs. This will guide disease indication selection and patient stratification, define biomarkers of disease activity and correlate biological response with clinical response/outcome
- Use extensive knowledge of inflammatory and autoimmune disease biology, and genetics to develop specific biomarker hypotheses
- Develop a translational strategy demonstrating the relevance of POM readouts in disease areas of interest and highlights competitive differentiation.
- Actively engage with clinical and research cross-functional teams to prioritize and select disease indications for Q32 Bio programs
- Establish external collaborations with key KOLs to support human disease translational strategy. This includes designing studies and gaining access to human disease samples and datasets, guiding the analysis and interpretation of results, and integrating findings into clinical development plans
- Oversee the discovery and development of pharmacodynamic and predictive biomarkers for clinical development candidates.
- Work with clinical development colleagues to facilitate translational biomarker efforts for clinical stage programs including assay development and management of CRO vendor relationships
- Drive and support clinical trial biomarker data analysis and interpretation
- Generate data and written packages related to human disease translational activities supporting regulatory submissions
- Manage CROs to carry out validation and clinical application of biomarker, PK and ADA assays
- Apply unbiased methods of marker discovery in clinical samples
- PhD or MD/PhD in a scientific discipline and a minimum of 15 years related experience.
- Track record of publications, grants, research awards and/or patents
- Experience in early stages of drug development, IND filings and clinical development a major plus
- Effective communicator and leader with excellent organizational skills
- A demonstrated record of cutting-edge research in translational immunology and inflammatory diseases and industry experience is desirable
- Strong communication skills (oral and written) and ability to articulate short- and long-term strategic goal
- Expert knowledge of state-of-the-art biomarker discovery technologies