Director, Clinical Development (MD)

Key Responsibilities

• Provide clinical and scientific leadership for one or more inflammation development programs.
• Develop and continually refine the Clinical Development Plan (CDP), including indication strategy, target populations, clinical sequencing, success criteria, and key development decisions.
• Lead the design and execution of early- and mid-stage clinical trials, including Phase 1b/2 proof-of-concept and dose-ranging studies.
• Translate complex immunology and human disease biology into testable clinical hypotheses and development strategy.
• Integrate clinical, translational, biomarker, pharmacologic, and competitive data to inform asset strategy and decision-making.
• Provide medical leadership for protocols, eligibility criteria, endpoints, safety monitoring, dose selection, and benefit-risk assessment.
• Partner closely and proactively with Clinical Operations, Biostatistics, Clinical Pharmacology, Translational Medicine, Research, Regulatory Affairs, Safety, Medical Affairs, and Commercial colleagues.
• Represent Clinical Development on cross-functional asset teams and contribute to governance presentations and development recommendations.
• Build and share institutional knowledge across the portfolio, contributing expertise beyond a single asset so that learnings, assumptions, and strategy are aligned across programs rather than siloed.
• Develop productive relationships with investigators, external scientific experts, and key opinion leaders.
• Contribute to regulatory strategy and health authority interactions, including preparation and review of clinical sections of regulatory documents.

Qualifications

Required

• MD, PhD, or equivalent advanced degree, with 6+ years of relevant experience in biopharmaceutical clinical development or academic clinical research.
• Demonstrated expertise in immunology, inflammation, or immune-mediated disease.
• Significant experience in biopharmaceutical clinical development and/or highly relevant academic clinical investigation.
• Experience designing, conducting, and interpreting interventional clinical trials.
• Strong command of trial design, endpoints, statistics, safety assessment, and drug development principles.
• Ability to critically evaluate emerging biological and clinical data and convert it into clear development decisions.
• Demonstrated success working through multidisciplinary teams and influencing without direct authority.
• Strong written and verbal communication skills, including translating complex science for non-specialist audiences.
• Comfort operating in a rapidly evolving environment where strategic and scientific questions remain open.

Preferred

• Clinical or development expertise in pulmonary/respiratory medicine or dermatology, ideally asthma, COPD, atopic dermatitis, hidradenitis suppurativa, or related inflammatory disease.
• Board certification or advanced training in pulmonary medicine, allergy/immunology, dermatology, rheumatology, or a related specialty.
• Experience developing small molecules and/or novel targeted modalities in immune-mediated disease.
• Experience spanning first-in-human through proof-of-concept and Phase 2, including dose selection and evidence-generation strategy.
• Experience developing and applying pharmacodynamic, translational, or patient-selection biomarkers.
• Experience contributing to INDs and FDA or global regulatory interactions.