Medical Director, Respiratory, Early Clinical Development

Benefits

Qualifications

• •Basic Qualifications: MD or PhD in respiratory sciences or related field Minimum of 5 years experience in industry or relevant clinical or research experience
• •Understanding of the drug development process, including clinical and non-clinical study design and execution
• •Demonstrated track record in delivering results
• •Outstanding verbal and written communication skills
• •Excellent analytical, problem solving and strategic planning skills
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Responsibilities

• •What You Will Do Asa Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets within the context of a respiratory clinical team
• •This will include the creation of overall clinical development plans and clinical study design as well writing protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies, all in close collaboration with internal and external partners and clinical research organizations
• •Experience in Respiratory Medicine is strongly preferred. The successful candidate will thrive in a fast-paced, proactive can-do culture, be a strong communicator, and a collaborator
• •Responsible for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and product in compliance with GCP
• •Provide guidance in the medical strategy and clinical/disease expertise to Research, Translational Medicine, Early and Late-stage Clinical Development and Commercial colleagues as part of across functional teams
• •Closely follow medical developments within respiratory diseases and disseminate new information within Clinical Development and the wider organization to transform trends and emerging data into agile and innovative clinical plans
• •Work closely and collaborate across early and late R&I clinical development, partner functions and wider AZ organization to ensure design and delivery of clinical development plans with high quality and speed
• •Represent Early Respiratory TSCD to external partners, including Investigators, key external experts and patient advocacy groups
• •Medical Lead for regulatory communication and preparation of higher level documents Ensures internal and external peer review of potential study/program design
• •Support qualification of pharmacodynamic/disease markers for early assessment of efficacy
• •Support establishing scientific collaborations with academic collaborators to support key advancing translational science activities As available, provide clinical strategic input to in-licensing opportunities
• •Understanding of clinical research methodology and biostatistics principles to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
• •Understanding of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States, Europe, and the rest of the world
• •Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
• •Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
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