
Website headcount AG
We are seeking a highly experienced and motivated Clinical Research Physician (Director Level) to lead and oversee clinical development programs in the field of autoimmune diseases. The ideal candidate will have a strong background in clinical research, a deep understanding of autoimmune disorders, and a proven track record of successfully advancing clinical trials from Phase I through Phase IV. This role requires strategic leadership, scientific expertise, and the ability to collaborate cross-functionally to drive the development of innovative therapies.
Essential Functions:
1. Global Clinical Development Strategy:
- Lead the design, planning, and execution of clinical trials for autoimmune disease therapies, ensuring alignment with regulatory requirements and company objectives.
- Provide medical and scientific expertise to guide the development of clinical protocols, study designs, and regulatory submissions.
2. Global Clinical Trial Oversight:
- Serve as the medical monitor for global clinical trials, ensuring patient safety, data integrity, and compliance with GCP and regulatory standards.
- Review and interpret clinical data, identify trends, and provide medical input for decision-making.
3. Cross-Functional Collaboration:
- Work closely with biostatistics, regulatory affairs, pharmacovigilance, and other teams across different regions to ensure seamless execution of clinical programs.
- Collaborate with external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory agencies in the EU, US, and other countries.
4. Scientific Leadership:
- Stay abreast of advancements in autoimmune disease research and contribute to the scientific direction of the company.
5. Mentorship and Team Development:
- Provide mentorship and guidance to junior clinical research staff, fostering a culture of excellence and innovation.
Experience / Education:
- Medical Degree (MD or equivalent) with board certification or equivalent in a relevant specialty (e.g., Rheumatology or Internal Medicine).
- Minimum of 5 years of industry experience in clinical research, preferably in autoimmune diseases.
- Proven track record of leading clinical trials and contributing to regulatory submissions (e.g., IND, NDA, BLA). Familiarity with global regulatory requirements and guidelines.
- Strong understanding of autoimmune disease pathophysiology, treatment landscape, and emerging therapies.
- Experience with biologics, small molecules, or novel therapeutic modalities in autoimmune diseases.