Executive Medical Director, Rheumatology, Early R&I Clinical Development

Role Summary

Executive Medical Director, Rheumatology, Early R&I Clinical Development. Provide medical leadership for preclinical and clinical stage assets across autoimmune indications, leading early phase development and cross-functional teams to shape clinical development plans and study design.

Responsibilities

• Lead the design, delivery and interpretation of clinical studies ensuring ethical and scientific integrity of plans, studies and product
• Provide medical strategy and clinical expertise to Research, Translational Medicine, Early and Late stage Clinical Development and Commercial Partners, including development of therapeutic area strategy
• Monitor medical developments within assigned areas and disseminate new information to transform trends into agile clinical plans
• Represent early R&I clinical development to external stakeholders including investigators, external experts, governmental/policy groups and patient advocacy groups
• Medical Lead for regulatory communication and preparation of higher level documents
• Ensure internal and external peer review of potential study/program design
• Support qualification of pharmacodynamic/disease markers for early efficacy assessment
• Provide clinical strategic input to in-licensing opportunities

Qualifications

• MD and/or PhD
• 10+ years of experience in clinical development in relevant immunology indications, with background in early clinical development (first in human through Ph2b)
• Demonstrated track record in leading cross-functional teams and delivering results
• Understanding of the entire drug development process, including clinical and non-clinical study design and execution
• Thorough understanding of clinical research methodology and biostatistics principles to facilitate innovative and efficient trial design and development plans with data-driven decision rules
• Familiarity with FDA, MHRA and ICH GCP guidelines for studies in US, Europe and elsewhere
• Attention to detail and ability to drive high-quality work with urgency to achieve goals
• Experience managing complex projects and collaborating with multiple stakeholders on new strategies to ensure consistent communication
• Excellent analytical, problem-solving and strategic planning skills
• Ability to thrive in a fast-paced environment

Skills

• Clinical leadership
• Strategic planning in immunology
• Regulatory communication
• Cross-functional collaboration
• Clinical study design and execution
• Biostatistics and research methodology
• Pharmacodynamic/biomarker qualification

Education

• MD and/or PhD

Additional Requirements

• Location: Boston, MA
• Travel: Not specified in source