Head of Translational Biology

The Position

Earli 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
• 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.
• Be the key external stakeholder to select and oversee CROs to conduct GLP safety and toxicology studies
• 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

The base salary for this position is $215k-$235k per year.