Medical Director, Rheumatology Clinical Development
Job Description
Medical Director, Rheumatology – Clinical Development
Position Summary
An innovative biotechnology organization focused on immune-mediated and inflammatory diseases is seeking an experienced Rheumatologist to serve as Medical Director within Clinical Development. This physician leader will play a critical role in advancing therapeutic programs from early development through late-stage clinical studies by providing strategic medical leadership, scientific expertise, and cross-functional collaboration.
The position requires deep knowledge of rheumatologic and autoimmune diseases, strong clinical judgment, and experience contributing to drug development programs in biotechnology or pharmaceutical settings.
Key Responsibilities
- Provide medical leadership for rheumatology and immunology clinical development programs.
- Lead the clinical strategy and execution of Phase I–IV clinical trials in autoimmune and inflammatory diseases.
- Author and review clinical protocols, investigator brochures, clinical study reports, safety narratives, and regulatory documents.
- Collaborate with translational medicine and biomarker teams to integrate precision medicine strategies into development programs.
- Serve as the medical monitor for clinical studies, including safety review and adverse event assessment.
- Interpret and communicate clinical data to internal stakeholders, investigators, regulatory agencies, and external partners.
- Support interactions with regulatory authorities, ethics committees, and institutional review boards.
- Develop relationships with key opinion leaders, investigators, academic collaborators, and advocacy organizations in rheumatology.
- Contribute to publication strategy, scientific presentations, and congress activities.
- Partner closely with clinical operations, biostatistics, regulatory affairs, pharmacovigilance, medical affairs, and research teams.
- Monitor competitive landscape, emerging therapies, and scientific advancements relevant to autoimmune and inflammatory diseases.
- Provide strategic input for indication selection, lifecycle planning, and portfolio development.
Qualifications
- MD or DO with board certification in Rheumatology.
- Active medical license preferred.
- Minimum of 5–8 years of clinical experience in rheumatology and/or biotechnology or pharmaceutical industry experience.
- Prior experience in clinical development, medical monitoring, or translational medicine strongly preferred.
- Strong understanding of autoimmune disease biology, immunology, and inflammatory pathways.
- Experience designing and managing clinical trials in rheumatologic or immunologic diseases.
- Familiarity with FDA, EMA, ICH-GCP, and global regulatory requirements.
- Demonstrated ability to analyze complex clinical and scientific data.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Ability to thrive in a fast-paced, innovation-driven environment.
Preferred Experience
- Rheumatoid arthritis
- Lupus and systemic autoimmune diseases
- Fibrotic and inflammatory disorders
- Biologic therapies and immune-targeted treatments
- Biomarker and translational research integration
- Early-stage biotechnology or emerging therapeutic platforms
Leadership Competencies
- Strategic scientific thinking
- Collaborative leadership
- Strong medical and ethical judgment
- Data-driven decision making
- Effective stakeholder engagement
- Adaptability and innovation mindset
Work Environment
- Highly collaborative and mission-driven culture
- Opportunity to shape Client therapies in immunology and inflammation
- Cross-functional engagement with research and executive leadership
- Hybrid or remote work flexibility based on organizational needs