Clinical Research Director, Rare Diseases

Main Responsibilities
- Create clinical development strategy and plans for one or more assets
- Lead cross-functional teams to design, implement, and execute clinical development plans and studies
- Align strategy with global project team and internal partners (clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing)
- Advance plans through internal management review; oversee execution in compliance with SOPs, GCP, ICH, and other regulations
- Lead a clinical sub-team to design studies and create study protocols; progress study execution proactively
- Review key documents (investigator brochure, IND/CTA materials, integrated development plan clinical sections, regulatory submission dossiers)
- Engage with health authorities (contribute to submissions and respond to regulatory reviews)
- Provide medical expert/strategic input for early-stage programs; collaborate with external experts, KOLs, and investigators
- Represent at scientific conferences and regulatory meetings

Scientific & Technical Expertise
- Maintain deep therapeutic-area scientific/technical/clinical expertise; stay current on relevant pre-clinical/clinical pharmacology and data
- Critically read and evaluate medical literature

Qualifications (Experience/Skills)
- MD or MD/PhD (preferably pulmonology) with at least 2 years clinical development experience (pharma, academia, or government such as NIH/FDA)
- Experience advancing assets from discovery to clinical development
- Experience with novel translational medicine approaches
- Strong leadership, matrix influence/collaboration, and communication/presentation skills
- Proven track record of publications and conference presentations

Benefits
- At least 14 weeks’ gender-neutral parental leave