Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology at AstraZeneca in Boston, Massachusetts

Job Description:

Are you ready to shape and deliver the AstraZeneca Immunology pipeline?


If you are a motivated drug developer, this is an excellent time to join!



Who We Are



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 2b), while collaborating closely with our late phase clinical development colleagues who guide our phase 3 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 phase 1-2b clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.



What You Will Do



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.

• 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.
  
  

Basic Qualifications:

• 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.
  
  

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. Join us in our unique and ambitious world.


The annual base salary for this position ranges from $265,780-$398,671. 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 included 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. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.




Why AstraZeneca?



Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.


Ready to make a meaningful impact on patients' lives? Apply now!


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now