Do you have expertise and scientific reputation in the Cardiovascular, Renal, Metabolic Diseases research area? Are you excited by a role where you will provide global scientific leadership within your area of expertise to accelerate innovative science and turn ideas into life changing medicines? Would you like to apply your expertise in a company where we work together across boundaries to make the impossible a reality? Join us to be part of the discovery of future treatments for Cardiovascular, Renal and Metabolic diseases. As a Senior Group Director in Boston, MA, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. The successful Study Clinical Lead in Late Phase CVRM will be responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as will allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.
What You'll Do: Line Management: Ensure consistent practices, compliance with internal SOPs, local regulations and laws, talent development, leadership development, best practice sharing, mentoring programs, coaching, training, and medical education in collaboration within line manager group and across late stage development units.Line management responsibility for physicians and scientists delivering performance management and guiding the professional development of direct reports. Ensure individuals are rewarded and recognized appropriately for success.Study Leadership: Provide strategic medical and scientific knowledge for assigned projects and study including the design, initiation, execution, completion, and interpretation of data.Deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites for assigned study.Maintain accountability for study design.Oversee Trial conduct and hands-on delivery of assigned study.Drive decisions within Study Team (ST) remits together with other ST members and for solving medical issues.Oversee the medical and ethical components of assigned study, including patient safety in compliance with GCP.Oversee the delivery of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans).Oversee safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and the escalation to the GCH/Global Safety Physician when needed.Hold medical accountability for international investigator meetings and support Marketing Companies (MC) in national activities.Approve (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).Oversee ST induction and education of new members in the study team, as well as others involved in the study.Collaborates seamlessly and efficiently with global colleagues at other R&D sites.Deliver analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation.Serve as a source of medical expertise for the Product Team, in analyses and interpretation of medical data.Basic Qualifications: M.D. degree OR graduate with a scientific doctorate (e.g. PhD or PharmD) or equivalent in a scientific discipline or Pharmaceutical Medicine.3+ years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results.Good knowledge of biostatistics, global regulatory environment and pharmacovigilance.Proven teamwork and collaboration skills.Fluent in oral and written English.Good presentation skills and effective communication.A clear demonstration of: Leadership skills, with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting.AstraZeneca values and behaviors.Agile responsiveness to scientific data.Credibility in scientific and commercial environments.Preferred Qualifications: Good general medical knowledge preferably in nephrology, cardiology, or metabolic disease.An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development.An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements.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.
As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Date Posted: 27-Nov-2024
Closing Date: 19-Dec-2024
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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