Medical Director, Respiratory, Early Clinical Development

About the role

Are you ready to shape and deliver the AstraZeneca Respiratory pipeline? If you are a motivated drug developer, this is an excellent time to join!

Responsibilities

• Provide medical and scientific input to preclinical and clinical stage assets within the context of a respiratory clinical team.
• Create overall clinical development plans and clinical study design, write protocols, key study and health authority documentation, medical monitoring, and ensure timely delivery of studies, all in close collaboration with internal and external partners and clinical research organizations.
• Guide 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.
• Ensure 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.

Requirements

• 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
• 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
• Demonstrated track record in delivering results
• Outstanding verbal and written communication skills
• Excellent analytical, problem solving and strategic planning skills

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
• 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
• Demonstrated track record in delivering results
• Outstanding verbal and written communication skills
• Excellent analytical, problem solving and strategic planning skills

Skills

• Strong understanding of respiratory diseases
• Expertise in clinical research methodology and biostatistics
• Knowledge of FDA, MHRA and ICH GCP guidelines
• Ability to manage complex projects and work collaboratively with multiple stakeholders
• Outstanding verbal and written communication skills
• Excellent analytical, problem-solving, and strategic planning skills

Benefits

The annual base salary for this position ranges from $249,827 - $374,740. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Pay

The annual base salary for this position ranges from $249,827 - $374,740. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Schedule

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.