Title: Medical Director, Clinical Development Location: Boston, Massachusetts, United States Job Description: 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 Medical Director, Clinical Development – is a therapeutic and disease area specialist who will play a key role in advancing innovative therapies for patients with immunology diseases through high-quality design and execution of clinical trials. In this role, you will provide medical leadership across a range of clinical development activities, including but not limited to: study design, study execution, the monitoring of patient safety, data interpretation, and contribution to regulatory and scientific deliverables. As an internal scientific leader in the field, you will provide input into the overall clinical development strategy for the asset and incorporate insights from key opinion leader interactions into both study design and development strategy. This role involves working closely with internal cross-functional partners across a range of disciplines to drive high-quality clinical programs in a fast-paced 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: - Lead and provide medical oversight for assigned clinical trials including; protocol development, study conduct, medical monitoring, data review & interpretation, and clinical study reporting. - Contribute to clinical development strategy and program plans by integrating scientific rationale, regulatory requirements, safety considerations, operational feasibility, and business objectives. - Provide medical leadership on trial design, including endpoint selection, eligibility criteria, dose rationale, biomarker strategy, risk-based monitoring, and interim analysis frameworks. - Monitor real time data collection throughout study conduct ensuring robust study conduct and protocol adherence. - Support pharmacovigilance activities during trial conduct — monitor patient safety and benefit-risk throughout study conduct through review of adverse events, serious adverse events, laboratory data, safety narratives, and aggregate safety information, and contribute to related safety governance activities in coordination with the Global PV Medical Director - Serve as a key medical resource for investigative sites, external advisors, and clinical investigators, ensuring patients meet the appropriate eligibility criteria, responding to clinical and safety inquiries and supporting external interactions, advisory boards, and scientific communications as appropriate. - Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform overall development strategy. - Review, author, and contribute to key clinical and regulatory documents, including protocols, protocol amendments, investigator brochures, informed consent forms, clinical study reports, briefing materials, and health authority responses. - Support regulatory interactions and submissions by providing medical and scientific input for agency meetings, annual reports, and clinical sections of regulatory filings. - Serve as the clinical development lead for an asset if required - Perform other duties and responsibilities as assigned Qualifications: - Education: Advanced clinical degree (MD or DO) or MD/PhD required. Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus. - Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience - Direct experience treating, or managing lupus (SLE and/or CLE)and/or systemic sclerosis patients/clinical programs strongly preferred. - Deep scientific expertise in autoimmune disease — rheumatology, specifically lupus (SLE and/or CLE) or systemic sclerosis, preferred. - Direct experience of phase 1-3 clinical studies in particular; authoring clinical trial protocols, clinical development plans and regulatory submission documents - Deep clinical and scientific expertise in immunology and inflammation— including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches - Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi-site, multinational clinical programs - Demonstrated ability to lead and influence cross-functional teams in a matrixed, fast-paced biotech or pharmaceutical environment without direct line authority - Proven ability to build alignment across diverse internal and external stakeholders, including senior leadership, clinical operations, regulatory, and commercial partners - Track record of driving program-level decisions with clarity and accountability, balancing scientific rigor with business urgency in resource-constrained settings - Exceptional scientific communication skills, with the ability to articulate complex medical and clinical data to senior leadership, health authorities, clinical investigators, and external partners. - Demonstrated scientific writing proficiency, including the ability to evaluate and present complex data sets in regulatory documents, clinical study reports, and scientific publications. - Skilled at facilitating high-stakes discussions — including advisory boards, cross-functional program reviews, and health authority interactions — with confidence and precision 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. Salary Range $266,000 - $340,000 USD 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.

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor • Often serves as primary medical contact for customers for assigned clinical studies • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department • Responsible for protocol design and development, upon request • Provides input into protocol amendments • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed • Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts • Provides medical input into data collection tools, monitoring plans, and review and analysis plans • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data • Provides after-hours medical coverage for clinical studies • Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans • Adheres to customer policies and standard operating procedures, as required in project plans • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines • May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request • May provide input to clinical development or regulatory teams within the Company, upon request • May represent the Company at scientific meetings, upon request

Role Description The Director of Regulatory Affairs position will serve as a key member of the Regulatory team and may provide regulatory support across all disciplines, as needed. This role will be responsible for assisting in all regulatory strategies, writing, and activities for the organization, including all communications with FDA and other regulatory bodies. Additionally, the Director will assist as a steward of the Regulatory Affairs processes, procedures, and compliance to facilitate effective execution by the regulatory function across the organization. Qualifications - Bachelor's degree in a related field; advanced degree or equivalent preferred - 10 years of experience in technical/regulatory roles in the pharmaceutical/biotech industry - 5 years of experience in Regulatory Affairs in pharmaceutical/biotech industry - 3 years of demonstrated success in a regulatory leadership role and proven management by influence - Direct experience with FDA interactions, including written and verbal interactions and negotiations - Direct experience in writing and crafting regulatory submissions - Demonstrated experience managing complex virtual and matrixed organizational structures - Demonstrated experience in developing effective and successful regulatory strategies for all aspects of development programs - Thorough drug development technical expertise across Pre-Clinical and/or Clinical disciplines, and CMC - Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner - Ability to provide effective project communications, verbal and written, tailored for specific audiences - Ability to translate complex information into a logical and credible plan - Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities - Demonstrated organizational skills and attention to detail - Familiarity with eCTD requirements and e-submission formats/processes - Experience in establishing portfolio and program Regulatory strategy from pre-Candidate Selection through Post-Licensure Requirements - Direct experience in leading a monoclonal antibody/protein therapeutic through the drug development process through BLA submission, approval, and launch of the product - Experience in commercialization of monoclonal antibody therapies - Advanced degree or equivalent in a related field - Experience in interacting and negotiating with non-US Regulatory Agencies - Experience with post-approval change management, comparability assessments, post-marketing commitments and overall product life cycle management - Experience with FDA Animal Rule requirements for licensing drugs - Experience with US government acquisition and procurement contracting and Project Management deliverables - Experience in supporting US Government grant or proposal planning and writing - Previous experience establishing effective working relationships in a virtual environment - Previous experience with mentoring and/or development of employees - Previous experience developing drugs for rare diseases/Orphan drugs - Previous experience with FDA's regulations on expanded access and/or emergency use authorization of investigational drugs - Previous experience working with regulatory authorities in developing countries and in resource limited environments - Ability to effectively work remote/virtual using telecons and web conferences Responsibilities - Ensures that all regulatory goals are met and are in compliance with current industry standards and global regulations - Serves as a steward of Regulatory Affairs processes, procedures, and tools - Contributes to coordination, preparation, and timely submission of all regulatory documents - Develops regulatory strategies for the company as well as for product development teams - Facilitates FDA interactions, presentations and negotiations - Interprets and disseminates FDA communications, expectations and decisions to internal and external stakeholders - Advises the Head of Regulatory Affairs, senior management, and program team members on the impact of the changing regulatory environment - Assists in providing direction to regulatory team members related to assignments, timelines, and prioritization of project goals Benefits - Medical, dental, and vision insurance benefits are available to eligible employees and their families - Basic life insurance, short and long term disability, and a 401K plan with Company contributions - 7 days of sick time, 13 paid holidays, and 18 days of vacation throughout the calendar year

• Develop, implement, educate and monitor clinical programs • Advise and support facilities in compliance with State and Federal regulations • Assist during disease outbreaks and prepare plan of corrections • Conduct training and oversee Regional DON meetings • Monitor facilities compliance with nursing standards and metrics