Clinical Research Director - Immunology and Inflammation

Main Responsibilities
- Develop, execute, and report clinical trials for product registration (Immunology and Inflammation; Solid Organ Transplant), reporting to the Clinical Lead.
- Develop abbreviated protocol and clinical protocols; participate in protocol, study report, and labeling review.
- Support interactions with regulatory agencies and ethics committees; serve as medical spokesperson at key regulatory meetings.
- Contribute to clinical strategy and plan; represent clinical function on Clinical Study Teams.
- Provide input into Translational Medicine Plan (biomarker strategy).
- Ensure timely development milestones (protocols, committees management, centralized monitoring, KRM/CSR at study end).
- Interact with opinion leaders and external consultants; serve as medical monitor for assigned studies.
- Ensure clinical data meets regulatory standards; support registrations and label submissions/modifications (IB, DSUR, Health Authority briefing package); participate in Advisory Committee preparation.
- Ensure timely submission and dissemination of clinical data; support advisory board planning; establish/maintain collaborations with knowledge experts.

Basic Qualifications (required/preferred)
- Medical Doctor with transplant, nephrology, hepatology, or immunology clinical expertise preferred.
- Minimum 2 years experience in pharmaceutical drug development and/or clinical research.

Preferred/Plus
- Phase 3 clinical development experience; proven scientific achievement (presentations/publications or major clinical studies/submissions).
- Strong scientific/academic background and deep disease understanding; clinical/pharmaceutical experience in transplant/immunology.
- Knowledge of drug development and immunology; networking ability in cross-cultural environments.
- Strong interpersonal, communication, presentation, and negotiation skills; performance-oriented, strategic execution; fluent English.