Associate Director, Nonclinical Program Development

Beeline Medicines • Boston, MA

2d • Hybrid

About The Position

The Associate Nonclinical Program Development Director will support the design, execution, interpretation, and integration of nonclinical safety strategies across Beeline's immunology and inflammation portfolio. This role is intended for a rigorously trained scientist with strong program management/operational skills who can help translate nonclinical safety (safety pharmacology, toxicology), PK/PD, biodistribution, and translational biomarker data into efficient development plans and submission-ready packages. The individual will partner closely with Toxicology, Early Development, Translational Medicine, Clinical Development, Clinical Pharmacology, Regulatory, CMC, Quality, Clinical Operations, Program Management, and external CRO/vendor partners to ensure nonclinical studies are designed, executed, interpreted, and documented to support IND-enabling packages, first-in-human (FIH) readiness, clinical progression, and future global marketing submissions. This position is tailored for a leader with experience driving nonclinical and translational programs in immune-mediated diseases, managing CROs, supporting IND submissions, designing fit-for-purpose nonclinical safety packages, contributing to biomarker strategies, and operating effectively in a fast-moving biotech environment.

Requirements

• PhD, DVM, PharmD, MS, or equivalent advanced degree in toxicology, pharmacology, immunology, cellular/molecular biology, biomedical sciences, or a related discipline.
• 7+ years of relevant biotechnology, pharmaceutical, CRO, academic translational research, or consulting experience, with meaningful experience supporting nonclinical development programs.
• Experience contributing to or leading nonclinical toxicology strategies for development-stage therapeutic programs, including IND-enabling study design and interpretation.
• Working knowledge of GLP toxicology studies, safety pharmacology, PK/PD, toxicokinetics, biodistribution, and regulatory expectations for nonclinical packages.
• Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities.
• Experience supporting FIH readiness, clinical biomarker strategy, or translational safety monitoring.
• Familiarity with regulatory interactions such as INTERACT, Pre-IND, IND, NDA/BLA or equivalent health authority submissions.
• Experience working with academic collaborators, external scientific consultants, and specialized translational or biomarker assay vendors.
• Experience reviewing or contributing to nonclinical study reports, IND/CTD sections, briefing packages, or other regulatory documents.
• Experience in a small biotech, startup, or virtual operating model where the role requires hands-on execution, vendor management, and strategic problem-solving
• Demonstrated ability to manage external CROs/vendors and coordinate study execution across multiple stakeholders
• Strong project/program management capability, including timeline planning, cross-functional coordination, risk tracking, deliverable management, and issue escalation.
• Ability to communicate scientific and operational issues clearly to cross-functional teams and senior stakeholders.

Responsibilities

• Support and help drive nonclinical toxicology strategy for assigned pipeline assets — contributing to integrated safety plans that include toxicology, toxicokinetics, safety pharmacology, immunotoxicology, reproductive/developmental toxicology, carcinogenicity considerations, and other modality-specific assessments required to support clinical development and regulatory filings.
• Provide program management/operational leadership for nonclinical development activities — building and maintaining study plans, timelines, risk logs, decision trackers, vendor deliverables, and cross-functional action plans to ensure nonclinical workstreams remain aligned with program milestones, governance expectations, and regulatory submission timelines.
• Support organization of central repositories by guiding systematic arrangement nonclinical reports and data sets in a consistent manner across programs.
• Oversee CRO and external partner execution — supporting CRO/vendor identification, selection, contracting input, study start-up, protocol review, study monitoring, issue escalation, quality oversight, GLP compliance expectations, data delivery, and final report review for nonclinical toxicology and translational studies.
• Contribute to IND-enabling and regulatory documentation — authoring, reviewing, and coordinating toxicology and nonclinical study report content, nonclinical regulatory sections, briefing book materials, responses to health authority questions, and study-level documentation required for INDs and other global submissions.
• Identify nonclinical safety risks and mitigation strategies — proactively assessing knowledge gaps, interpreting emerging nonclinical data, integrating cross-functional input, and proposing pragmatic mitigation plans that enable timely, science-based decisions in a resource-conscious biotech environment.
• Partner with Translational Medicine and Clinical Development to bridge nonclinical findings to clinical monitoring — helping align nonclinical safety observations, translational biomarkers, sample collection plans, lab readiness activities, and clinical monitoring approaches for first-in-human and clinical studies.
• Collaborate effectively across matrixed teams — working with Toxicology, Translational Medicine, Clinical Pharmacology, Regulatory, CMC, Quality, Clinical Development, Program Management, medical writing, academic collaborators, consultants, and CRO partners to ensure integrated execution, clear Perform other duties and responsibilities as assigned

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree