The PositionEarli is currently seeking a Senior Director, In Vivo Pharmacology to oversee and lead the In vivo/Translational biology group. The successful candidate will have a proven track record of successfully initiating and advancing pharmacology and translational science projects across oncology indications from Discovery through IND enabling studies and beyond. She/he will be responsible for working with company scientific leadership for the design and planning of in vivo preclinical studies to characterize the efficacy, PK/PD and safety of Earli's drug candidates. This position will report to the SVP of Platform R&D.
Primary responsibilities- Oversee and manage the In vivo/Translational Biology group at Earli to support the growth and expansion of the team
- Develop preclinical strategy for advancing Earli's candidate pipeline in immuno-oncology, including selection of appropriate in vivo models, efficacy, safety, PK/PD characterization, and development of translational biomarkers to support FIH clinical studies
- Help lead operational planning and oversight of internal and external in vivo studies
- Be the key stakeholder to select and oversee CROs to conduct external non-GLP and GLP safety and toxicology studies
- Help author nonclinical sections of regulatory filings, including the production of high-quality technical reports including statistical analyses and data integrity review for these filings
- Proactively foster the growth of team members and identify opportunities for staff to develop into top-tier, independent pharmacology team members
- 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- Required Experience, Knowledge, and Skills
- Proven track record leading nonclinical safety, pharmacology, and biomarker strategies to support development of nucleic acid therapeutics through IND filing and beyond
- A deep understanding of the design of safety and efficacy studies of viral or non-viral genetic medicines (mRNA-LNPs or DNA-LNPs preferred) using systemic, repeat administration. Proven translation of programs from Discovery into human clinical studies is highly desired.
- Strong and documented first-hand experience in leveraging state-of-the-art immuno-oncology preclinical models, especially humanized models and orthotopic/metastatic as well as GEMM/transgenic cancer models for use in therapeutics development
- Proven ability to oversee the development and validation of new models. Experience working with atypical and larger preclinical cancer models (e.g. dogs) 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.
If interested in applying, please attach a CV or have a well-developed LinkedIn profile for us to be able to assess your background.
We look forward to hearing from you!
