Medical Director, Clinical Development

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. 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 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: Hybrid, 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.

Responsibilities

Lead and provide medical oversight for assigned clinical trials, including protocol development, study conduct, medical monitoring, data review and 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, including monitoring patient safety and benefit-risk through review of adverse events, serious adverse events, laboratory data, safety narratives, and aggregate safety information, 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 eligibility criteria and responding to clinical and safety inquiries; Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs; 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

Requirements

Advanced clinical degree (MD or DO) or MD/PhD; Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience; Direct experience of phase 1-3 clinical studies, including authoring clinical trial protocols, clinical development plans and regulatory submission documents; Deep clinical and scientific expertise in immunology and inflammation, including 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, including articulating complex medical and clinical data to senior leadership, health authorities, clinical investigators, and external partners; Demonstrated scientific writing proficiency, including evaluating and presenting 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

Nice to have

Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty; Additional advanced degree (PhD, MPH, or MBA); Direct experience treating or managing lupus (SLE and/or CLE) and/or systemic sclerosis patients/clinical programs; Deep scientific expertise in autoimmune disease, specifically lupus (SLE and/or CLE) or systemic sclerosis

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; A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance