Clinical Research Director, Rare Diseases

Main Responsibilities:
- Create clinical development strategy and plans for one or more assets.
- Lead and coordinate 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 the clinical development plan through internal management review.
- Lead a clinical sub-team to design studies and create study protocols.
- Execute the plan in close collaboration with clinical operations.
- Advance scientific and clinical knowledge in rare diseases; incorporate new trial, scientific, and digital methodologies.
- Pro-actively progress study execution; oversee execution in compliance with SOPs, GCP, ICH, and applicable regulations.
- Review clinical development documents (e.g., Investigator’s brochure, IND/CTA regulatory documents, integrated development plan clinical sections, regulatory submission dossiers).
- Engage with health authorities (contribute to submissions and timely responses to reviews).
- Serve as a medical expert; provide strategic input to early-stage programs.
- Collaborate with external experts, key opinion leaders, and investigators.
- Represent the company at scientific conferences and regulatory meetings.

Qualifications/Skills:
- MD or MD/PhD in a relevant scientific discipline (preferably pulmonology) with at least 2 years of relevant clinical development experience.
- Experience advancing assets from discovery into clinical development.
- Experience with novel translational medicine approaches.
- Strong leadership and matrix collaboration; excellent communication/presentation.
- Deep, up-to-date knowledge of pre-clinical/clinical pharmacology and data in the therapeutic area.
- Proven track record of scientific publications and international conference presentations.