Associate Director, Nonclinical Program Development

Beeline Medicines; Boston (MA); Hybrid; USD 181,000 - 214,000; Full time

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

Associate Director, Nonclinical Program Development

About Beeline Medicines:

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

Job Summary:

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.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and 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

Qualifications:

• Education: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.

Salary Range

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by applicable local law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance.

$181,000 - $214,000 USD

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• 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

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.