Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology

AstraZeneca • Boston, MA

47d • Hybrid

About The Position

In the Respiratory and Immunology Early Clinical Development team, we are investigating the drivers of key respiratory and immunology diseases, with access to pioneering science, innovative drug discovery approaches and key collaborations with academic centers around the world. We are investigating a wide range of drug modalities – small molecules, biologics, oligonucleotides and cell therapies – across multiple diseases with high unmet medical need. Early Clinical Development in R&I is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 – Phase 2), while collaborating closely with our late phase clinical development colleagues who guide later phase clinical studies. We are a diverse team of experienced physicians and clinical scientists who collaborate with scientists and translational medicine colleagues to define our early phase clinical development strategies, design innovative clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations. As the Senior Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets focused on Rheumatology/Clinical Immunology. You will take responsibility for clinical development in cross-functional teams to support early phase clinical development activities. These 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 Rheumatology drug development is a must and will ideally include trials in diseases such as systemic lupus erythematosus (SLE) and Rheumatoid Arthritis (RA). The successful candidate will thrive in a fast-paced, proactive can-do culture, be a strong communicator and collaborator.

Requirements

• Advanced degree in Rheumatology/Clinical Immunology (MD or PhD).
• Minimum of 7 years combined industry or relevant clinical or research experience.
• A background working in clinical development. Experience in Rheumatology or Immunology in a pharmaceutical or biotechnology company including knowledge and experience in the design and execution of clinical trials in diseases such as systemic lupus erythematosus or rheumatoid arthritis.
• 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 clinical trial design, and clinical development plans with clear data-driven decision rules.
• Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States, Europe and rest of 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.

Responsibilities

• 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 a cross functional teams.
• Closely follow medical developments within the autoimmune / inflammatory diseases and disseminate new information within Clinical Development and the wider organisation 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 R&I Clinical Development 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/programme design.
• Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
• As available, provide clinical strategic input to in-licensing opportunities.

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees