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

AstraZeneca-posted 2 months ago
$323,216 - $484,824/Yr
Full-time
Boston, MA
5,001-10,000 employees
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Be a disruptor in Immunology. We intend to show the world what science can do as we strive to transform outcomes for those living with immune-mediated diseases. Join us and help shape the future of our Immunology pipeline and innovative programs. In this role, you will provide medical leadership for preclinical and clinical stage assets, across indications such as SLE, Systemic Sclerosis, Sjogren’s and Rheumatoid arthritis, and spanning multiple modalities (small molecules, monoclonal antibodies, bi-specific and tri-specific antibodies, oligonucleotides). You will provide clinical development leadership for 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, medical monitoring and ensuring timely execution of studies, all in close collaboration with relevant internal and external partners and clinical research organizations, and involvement in in-scope external innovation / business development activities.

  • Lead the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and the product.
  • Provide impactful medical strategy and clinical expertise to Research, Translational Medicine, Early and Late stage Clinical Development and Commercial Partners, including in the development of therapeutic area strategy.
  • Closely follow medical developments within assigned areas and disseminate new information within Clinical Development and wider organization, to transform trends and emerging data into agile clinical plans.
  • Represent early R&I clinical development to external stakeholders, including investigators, key external experts, governmental/policy groups and community/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.
  • Provide clinical strategic input to in-licensing opportunities.
  • MD and/or PhD.
  • 10+ years of experience in clinical development in relevant immunology indications, with background working 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 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 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.
  • Excellent analytical, problem-solving and strategic planning skills.
  • Ability to thrive in a fast-paced environment.
  • 401(k) plan
  • paid vacation and holidays
  • paid leaves
  • health benefits including medical, prescription drug, dental, and vision coverage
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