Recode Therapeutics - Menlo Park, CA
posted 4 months ago
ReCode Therapeutics is a clinical-stage genetic medicines company that is pioneering the use of precision delivery systems to enhance the efficacy of mRNA and gene correction therapeutics. The company’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform allows for targeted delivery of genetic medicines to specific organs, tissues, and cells, which is crucial for treating diseases effectively. ReCode's lead programs, RCT1100 and RCT2100, are focused on treating primary ciliary dyskinesia and cystic fibrosis, respectively, utilizing inhaled mRNA-based therapies formulated with the SORT LNP delivery system. As the company expands its pipeline, it aims to develop therapies for a range of genetic diseases, including those affecting the musculoskeletal system, central nervous system, liver, and infectious diseases. In the role of Senior/Executive Director of Translational Sciences & Nonclinical Operations, you will be a key leader within ReCode Therapeutics, reporting directly to the Senior Vice President of Early Development. This position is critical for shaping the nonclinical and translational sciences strategy, ensuring that it aligns with clinical development plans, and effectively navigating the regulatory pathways necessary for clinical development and marketing approvals. You will oversee various teams, including Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology, ensuring that they provide robust support for clinical development programs. Your leadership will be essential in delivering high-quality data packages to regulatory authorities and collaborating with cross-functional teams to align nonclinical deliverables with clinical objectives. The position requires a proactive approach to developing and implementing strategic plans for nonclinical operations, anticipating challenges, and ensuring the organization is prepared to address them. You will also be responsible for maintaining awareness of the evolving scientific and regulatory landscapes, which will inform the design of approval pathways. Additionally, you will identify and manage external consultants and subject matter experts to enhance functional strategies based on the latest scientific insights. This role also involves fostering collaborations with key opinion leaders and external partners, supporting the preparation of regulatory submissions, and mentoring project leads in a matrix environment. The opportunity exists to take on full project team leadership responsibilities for dedicated programs based on your interests and bandwidth.