Sr Director, In Vivo Pharmacology

Earli; Redwood City (CA); On-site; USD 215,000 - 235,000; Full time

Job summary

Earli is seeking a Senior Director, In Vivo Pharmacology to lead the In vivo/Translational Biology group and advance pharmacology programs from Discovery through IND enabling studies in oncology.

The role reports to the SVP of Platform R&D and requires a track record in nonclinical safety, translational biology, and biomarker strategies. You will manage CROs, mentor staff and present findings to leadership.

Qualifications

• 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.

Responsibilities

• Oversee and manage the In vivo/Translational Biology group to support growth.
• Develop preclinical strategy for immuno-oncology pipeline including in vivo models and translational biomarkers.
• Lead operational planning and oversight of internal and external in vivo studies.
• Oversee CROs for external non-GLP and GLP safety/toxicology studies.
• Assist the regulatory filings with nonclinical sections and high-quality reports.
• Foster growth of team members and identify development opportunities.
• Present key findings at internal and external meetings.

Skills

Nonclinical safety

Pharmacology

Biomarker strategy

IND filings

Immuno-oncology models

Regulatory writing

Team leadership

Communication

Education

Ph.D. in Pharmacology

DABT preferred

Pharm.D./M.S. with 8+ years

Job description

Earli tackles the #1 problem in the $100B cancer drug market: systemic toxicity. On-target/off-tumor effects force suboptimal dosing, reduced efficacy and sidelining some of the most potent drug classes such as cytokines. Earli’s BioAI approach flips this paradigm: Drugs are produced only where needed— in the tumor, by the tumor, against the tumor. Cancer cells become their own drug factories, enabling localized immune activation, even in cold tumors.

This Was Enabled By Three Core Innovations

• Extrahepatic lipid nanoparticles (LNPs) that reach tumors such as lung cancer
• AI-designed genetic switches that activate only in malignant cells by sensing transcription factor dysregulation
• Local production of immune therapies (TCEs, cytokines, multispecifics) at the tumor site — “produce locally, consume locally”

Together, these technologies create a new biological control layer, allowing tumors to self-identify and trigger their own targeted immune attack—achieving specificity beyond current targeted or IO therapies.

Earli plans to enter the clinic by mid-2027 with a Phase 1/2 lung cancer trial. The company is backed by a16z, Khosla, Perceptive, Alex Gorsky, Marc Benioff, Breyer, Emerson Collective, Sands Capital and others. The SAB includes Jim Allison (Nobel Laureate, MD Anderson), Bob Langer (Co-founder Moderna, MIT), Phil Greenberg (Co-founder Juno), Amy Abernethy (frm. Principal Deputy FDA Commissioner), Bill Hait (former J&J EVP Oncology R&D), and Alan Ashworth (President UCSF Cancer Center). The leadership team brings deep gene therapy, LNP, CMC and tech experience; CEO Cyriac Roeding previously led a $250M (11x return) exit.

Who You Are

• You share our same sense of dedication, scientific passion and entrepreneurial spirit
• You work well in a fast-paced and extremely focused startup environment
• You are not only smart, but clever and constantly think outside the box
• You are able to make logical decisions in an instant when there is little time to evaluate
• You are a natural communicator and relationship builder
• You stay calm under high pressure and stress
• You have the ability to multi-task in a serious way, with an extreme attention to detail
• You become a representative of the core DNA of the company through who you are

The Position

Earli 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.

We look forward to hearing from you!