Senior Nonclinical Program Lead – Immunology

Beeline Medicines

Boston (MA)

Hybrid

USD 181,000 - 214,000

Full time

2 days ago
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Job summary

Beeline Medicines is seeking an Associate Director of Nonclinical Program Development to lead design, execution, and interpretation of nonclinical safety strategies across immunology and inflammation programs. This role collaborates across Toxicology, Early Development, Translational Medicine, Regulatory, and CRO partners to ensure IND-enabling packages and FIH readiness.

The position requires a PhD/MD-equivalent with 7+ years in nonclinical development, strong program management, and experience

Qualifications

  • PhD, DVM, PharmD, MS, or equivalent advanced degree in toxicology, pharmacology, immunology, cellular/molecular biology, biomedical sciences, or related discipline.
  • 7+ years of relevant biotech, pharmaceutical, CRO, academic translational research, or consulting experience.
  • Experience with IND-enabling study design and interpretation.
  • Knowledge of GLP toxicology, safety pharmacology, PK/PD, toxicokinetics, biodistribution, regulatory expectations.

Responsibilities

  • Support nonclinical toxicology strategy across assigned pipeline assets and integrated safety plans.
  • Provide program management/operational leadership for nonclinical development activities.
  • Oversee CRO/external partner execution and study delivery in GLP contexts.
  • Contribute to IND-enabling and regulatory documentation for submissions.
  • Identify and mitigate nonclinical safety risks with cross-functional input.
  • Bridge nonclinical findings to clinical monitoring with Translational Medicine and Clinical Development.

Skills

Nonclinical toxicology
IND readiness
Regulatory submissions
CRO management
Translational biomarkers
Team leadership
Program management

Education

Advanced degree

Job description

Beeline Medicines is seeking an Associate Director of Nonclinical Program Development to lead design, execution, and interpretation of nonclinical safety strategies across immunology and inflammation programs. This role collaborates across Toxicology, Early Development, Translational Medicine, Regulatory, and CRO partners to ensure IND-enabling packages and FIH readiness.

The position requires a PhD/MD-equivalent with 7+ years in nonclinical development, strong program management, and experience

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