The PositionEarli is currently seeking a Head of Translational Biology to oversee and lead the translational/in vivo biology group. The successful candidate will have a proven track record of successfully initiating and managing pharmacology and translational science projects across oncology indications from Discovery through IND enabling studies. She/he will be responsible for working with the existing scientific leadership for the design and planning of in vivo preclinical studies to characterize the efficacy, PK/PD and safety properties of Earli's proprietary compounds. This position will report to the Chief Scientific Officer.
Primary Responsibilities
• Oversee and manage the Translational Biology group at Earli to support the growth and expansion of the team • Proactively foster the growth of team members and identify opportunities for staff to develop into top-tier, independent pharmacology team members • Design safety and toxicity preclinical studies to support entry of Earli compounds • Be the key external stakeholder to select and oversee CROs to conduct GLP safety and toxicology studies • Help lead strategic planning and oversight of internal and external efforts to assess efficacy and safety testing of Earli's compounds for therapeutic applications across multiple pre-clinical in vivo models • Ensure the production of high-quality technical reports including statistical analyses and data integrity review to support regulatory submissions • Present key findings at internal and external meetings
Education Requirements:
Ph.D. in Pharmacology, Pharmaceutical Sciences, Toxicology or related discipline DABT preferred, but not required Candidates with a Pharm.D. or M.S. and 8 or more years leading nonclinical safety programs will be considered, especially with a background in the development of nucleic acid-based drugs.
Required Experience, Knowledge and Skills:
• Proven track record leading nonclinical safety and PK strategies to support development of nucleic acid therapeutics through IND filing • A deep understanding in the design of safety and efficacy studies of mRNA-LNPs (and ideally DNA-LNPs) using a multi-dose regimen • Translatability of those results into human clinical use is highly desired • Strong and documented first-hand experience in leveraging standard oncology models such as syngeneic, orthotopic, metastatic and GEMM/transgenic cancer models for the use in therapeutics development • Proven ability to oversee the development of new model systems • Experience working with atypical and larger preclinical cancer models is a plus • Successful demonstration of ability to rigorously analyze and interpret diverse, multidisciplinary data sets • Significant experience working with CROs to design and execute external studies • Significant experience in writing regulatory documentation to support IND filings • Previous experience in managing small to medium-sized groups is required • Excellent verbal communication and interpersonal skills are required
As a key member that directly influences strategy, you must be able to think independently, effectively communicate and fully integrate into a high-achieving team.