Associated Director Translational Research CVR&H
BioSpace · Waltham, MA · 1 wk ago
AnalystFull-time
Main Responsibilities
- Design, implement, and oversee translational and non-interventional biomarker studies, including protocol development in the fields of Cardiovascular & Renal including data analysis, and quality assurance.
- Contribute to biomarker strategies for toxicology and early clinical studies, by fully leveraging all elements for generation of Integrated Translational Evidence, i.e systematic literature reviews, integration of real-world data/evidence, insights gained from post-hoc studies and from prospective, non-interventional research studies (NIRS).
- Lead and support mechanism of action studies, biomarker discovery and development, and target validation using in vitro, ex vivo, and in vivo models, working closely with the internal Pharmacology Unit or external partners/vendors to access lab capabilities (e.g., academic institutions, biotech companies).
- Provide scientific and operational guidance to R&D projects across preclinical and clinical phases.
- Represent TR in TA Research core teams and RPTs; closely liaise with RTALs to support research strategies
- Represent Translational Research in global cross-functional teams, such as PSTs, NCETs and BETs, working closely with pre-clinical Pharmacology, Clinical Bioanalytics and Biomarkers, Clinical Pharmacology, Data Science and Early Clinical Development functions.
- Contribute to regulatory submissions, investigator brochures, and scientific publications.
- Supervise and mentor research scientists (e.g. from internal Pharmacology Units ), ensuring delivery of TA-aligned research packages.
Qualifications And Experience
- PhD, MD-PhD or equivalent in a relevant discipline (e.g., Biochemistry, Cell Biology, Immunology, Molecular Biology, Epidemiology), specific expertise in diseases relevant to CSL’s TA Strategies is a prerequisite.
- Minimum of 8–10 years of relevant experience in industry and/or academia, with a strong track record in translational research.
- Proven expertise in biomarker discovery, non-interventional study design, and translational biology.
- Experience in integrating clinical and scientific data to inform hypothesis generation and clinical development.
- Strong knowledge of epidemiological and statistical methods applied to translational and observational studies.
- Demonstrated leadership and people management skills in a matrixed, cross-functional environment.
- Excellent communication, analytical, and strategic thinking skills.
- Experience in regulatory documentation, scientific writing, and external collaborations.
- Ability to work effectively in multicultural and international teams.