Clinical Research Director, Immunology & Inflammation (Rheumatology)

Role Summary

The Clinical Research Director, Immunology & Inflammation (Rheumatology) is responsible for creating and executing the clinical development plan for one or more assets, aligning with project strategy, and coordinating with cross-functional teams to advance innovative therapies for autoimmune and inflammatory diseases, with a focus on rheumatology.

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 clinical development strategy with the 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 clinical studies and to create study protocols
• Execute the clinical development plan in close collaboration with clinical operations
• Advance scientific and clinical knowledge for immunology in rheumatologic diseases
• Incorporate new trial, scientific and digital methodologies
• Progress study execution pro-actively
• Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
• Review documents supporting clinical development (Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, submission dossiers for regulatory approval)
• Engage with health authorities and contribute to submissions and regulatory responses
• Serve as a medical expert and provide strategic input to early-stage programs
• Collaborate with external experts, key opinion leaders, and investigators to advance clinical research
• Represent the company at scientific conferences and regulatory meetings

Qualifications

• MD or MD/PhD in a relevant scientific discipline with at least 2 years of relevant experience in clinical development within the pharmaceutical industry, academia, or regulatory agencies
• Experience in advancing assets from discovery into clinical development
• Experience with translational medicine approaches
• Deep scientific, technical, and clinical knowledge in immunologic/rheumatologic diseases
• Expertise in autoimmune and inflammatory diseases, particularly rheumatology
• Strong problem-solving abilities
• Understanding of pre-clinical, clinical pharmacology, and clinical data relevant to the therapeutic area
• Strong leadership and collaboration skills in a matrix environment
• Excellent communication and presentation skills for diverse audiences
• Proven track record of scientific publications and presentations at international conferences

Skills

• Strategic thinking and leadership
• Cross-functional collaboration
• Effective scientific communication
• Regulatory and clinical development knowledge

Education

• MD or MD/PhD degree required