Associate Director, Nonclinical Program Development

About Beeline Medicines:

Beeline Medicines is a clinicalstage 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 Beelines 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.

Benefits:

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
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements local regulations and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity:

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 to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S. Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines