Executive Director, Preclinical and Translational Sciences

About the role

Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY This Executive Director position will report to the Senior Vice President, Research & Early-Stage Product Development and lead a team of translational scientists and drug development experts tasked with bringing innovative gene therapies to patients. The incumbent will have a high level of passion for 4DMT's mission and the ability to operate as an effective strategic and tactical thinker. They will also be effective as a hands-on manager and supervisor of individual work. Candidates should have a PhD or MD/PhD degree (or equivalent) in Biological Sciences or a related discipline, with significant experience in pharmaceutical research and development. They will lead a preclinical and translational group responsible for: (1) developing target-engagement biomarkers and clinical biomarkers with relevance to Proof of Concept (POC) gene therapy studies, (2) conducting laboratory and in silico analyses of biomarker readouts generated in the relevant Phase 1 and Phase 2 gene therapy studies, (3) performing immunological assays and analyses relevant to detecting host immune responses to 4DMT gene therapy vectors in the clinical trial setting, and (4) overseeing outsourced performance of preclinical pharmacology and toxicology studies of 4DMT gene therapy vectors, in partnership with external CROs. This role will interact and collaborate with multiple functions at 4DMT, including but not limited to Clinical Science and Operations, Regulatory Affairs, Discovery & Innovation, Commercial, and CMC. MAJOR DUTIES & RESPONSIBILITIES: Set, communicate and drive strategy for Translational products in alignment with the broader organization of 4DMT Prioritize and allocate resources, both within Translational and beyond, to meet portfolio needs Lead the decision-making process with other relevant functional group heads regarding indications, targets and products' progression from concept, design, preclinical development and Phase 1-2 clinical testing. Provide input on scientific strategy from the earliest consideration of new targets through development, including risk, scientific challenges, timing of resource investment and development of go/no go decisions ‪Direct and coordinate the implementation of preclinical study programs for pharmacology studies in support of the lead to candidate optimization process ‪Design, implement and write-up comprehensive series of pharmacology studies to address preclinical exposure, develop pharmacokinetics and pharmacodynamics profiles and generate GLP toxicology and bio-distribution packages suitable for supporting IND filings Manage budgets and headcounts ‪Design, implement and manage externally facing in vivo studies with CROs and academic centers, including drafting proposals, budget oversight and managing deliverables Resource planning; hiring and mentoring talents; building the team and technical capabilities Build collaborations with relevant functions at 4DMT; represent own function at the corporate level and externally Provide direct hands-on responsibility for all Translational interactions as well as grant writing and management with rare disease advocacy groups Participate on project teams and direct activities to ensure regulatory compliance of pre-clinical and clinical research activities Support regulatory affairs in their preparation, review and submission of necessary pre-clinical and clinical regulatory information to regulatory agencies worldwide Contribute to defining of clear human POC study outcome criteria for decision-making on new product candidates Contribute senior level expertise to alliance, busin

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