Medical Director, Clinical Development – Immunology

Beeline Medicines•Boston, MA

6h•$235,000 - $296,000•Hybrid

About The Position

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