Medical Director, Clinical Development – Immunology

Beeline Medicines • Boston, MA

9d • Hybrid

About The Position

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 Medical Director, Clinical Development – Immunology serves as the scientific and strategic lead for an early-stage immunology portfolio, with primary accountability for advancing assets from pre-IND activities through first-in-human (FIH) and Phase 2 clinical proof of concept. This role sits at the intersection of translational science and clinical execution, translating biological hypotheses into rigorous, value-generating development plans. The Medical Director operates as a cross-functional leader — partnering closely with Regulatory Affairs, Biomarker/Translational Medicine, Clinical Pharmacology, Biostatistics, and Commercial — to ensure that clinical programs are designed with scientific rigor, regulatory compliance, and patient safety as foundational priorities. This is a high-visibility, high-impact role for a physician-scientist who thrives in a fast-paced, resource-focused biotech environment and brings both strategic depth and hands-on ownership to early clinical development.

Requirements

• MD (or MD/PhD) with ideally previous experience in Immunology (e.g. Rheumatology, Dermatology, Gastroenterology, Pulmonology, Allergy, or a related field). Alternatively, PhD or PharmD will be considered based on track records of drug development experience
• 5 years of clinical development experience in biotech or pharmaceutical industry, with direct, hands-on leadership of Phase 1–3 clinical studies from protocol development through study completion.
• Proven experience authoring clinical protocols, clinical development plans, and regulatory submission documents, including pre-IND and IND/CTA packages.
• Demonstrated knowledge in biomarker strategy for immunology assets
• Exposure to adaptive designs, Bayesian approaches, quantitative decision criteria, or personalized medicine
• Demonstrated expertise in biomarker strategy development for immunology or inflammatory disease assets, with an understanding of how translational data informs clinical decision-making.
• Publications or presentations related to early clinical development, biomarkers, immunology mechanisms of action or academic publications.
• Solid grounding in clinical pharmacology principles, including PK/PD modeling, dose selection methodology, and the interpretation of exposure-response data in early-phase studies.
• Comprehensive knowledge of ICH-GCP guidelines and experience conducting global clinical trials across major regulatory jurisdictions, including FDA, EMA, MHRA, and PMDA frameworks.
• Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi-site, multinational clinical programs.
• 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.
• Demonstrated ability to lead and influence cross-functional teams in a matrixed, fast-paced biotech or pharmaceutical environment without direct line authority
• Track record of driving program-level decisions with clarity and accountability, balancing scientific rigor with business urgency in resource-constrained settings
• Experience fostering a culture of high performance, inclusion, and continuous learning
• Proven ability to build alignment across diverse internal and external stakeholders, including senior leadership, clinical operations, regulatory, and commercial partners
• Exceptional ability to translate complex scientific and clinical concepts into clear, compelling narratives tailored to diverse audiences, including executives, health authorities, and clinical investigators
• Strong scientific writing skills, with demonstrated experience authoring regulatory documents, clinical study reports, protocols, and/or peer-reviewed publications
• Skilled at facilitating high-stakes discussions — including advisory boards, cross-functional program reviews, and health authority interactions — with confidence and precision
• Effective at delivering data-driven recommendations and updates to senior leadership, adapting communication style to drive informed decision-making at the organizational level

Responsibilities

• Serve as the medical lead for FIH and/or Phase 2 clinical trials, owning protocol development, medical monitoring, data review and interpretation, and clinical study reporting from study initiation through final analysis.
• Build and maintain robust Clinical Development Plans (CDPs) for assigned assets by integrating scientific rationale, regulatory requirements, product development strategy, and commercial objectives into a cohesive, decision-rule-driven roadmap.
• Support pre-IND activities and lead medical contributions to IND/CTA submissions, ensuring efficient and compliant progression from research into first clinical use.
• Partner with Clinical Operations, Pharmacovigilance, and Program Leadership to proactively address timelines, patient safety, risk identification and mitigation, and quality standards across global clinical studies.
• Collaborate with Biostatistics, Data Science, and Clinical Pharmacology to drive study design decisions, dose selection rationale, quantitative decision criteria, and interim analysis frameworks.
• Partner with the Biomarker and Translational Medicine teams to develop and implement biomarker strategies that demonstrate early biologic activity and inform go/no-go decisions at key clinical milestones.
• Engage and manage relationships with clinical investigators, key opinion leaders (KOLs), and external advisors; support advisory boards, medical conference presentations, and congress abstracts in alignment with publication strategy and compliance standards.
• Contribute to regulatory interactions with health authorities (e.g., FDA Type B meetings, EMA scientific advice), including preparation of briefing documents, background packages, and responses to agency queries.
• Provide clinical input into benefit-risk assessments, informed consent documents, Data Safety Monitoring Board (DSMB) charters, and safety reporting frameworks to ensure the highest standards of patient protection.
• Represent the clinical development function in cross-functional program teams and with senior leadership, communicating complex scientific and medical concepts with clarity and strategic perspective.
• Perform other duties and responsibilities as assigned

Benefits

• Medical, Dental & Vision insurance (employee premiums 100% covered by company)
• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
• Flexible work arrangements / hybrid schedule
• Health Savings Account (HSA)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior