Medical Director, Kidney Disease, Early Clinical Development CVRM
2 weeks ago
You will be responsible for managing and leading to early phase I-II global clinical trials and related clinical research projects for compounds that are targeting kidney disease, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additionally, you will work on cross‑functional teams within our TSCD group and across the broader global CVRM organization that are framing our strategies and development plans for compounds that are targeting cardiovascular diseases such as Heart Failure, as well as major metabolic disorders, such as Type 2 Diabetes, Obesity, and Metabolic Dysfunction‑Associated Steatohepatitis, given that these disorders intersect with chronic kidney disease and influence disease progression. Responsibilities Lead early Phase I-II global trials in kidneydisease: clinical strategy, protocol design, studyconduct, monitoring, data interpretation, and reporting, ensuringscientificintegrity, patient safety, and regulatorycompliance. Provide clinical leadership to cross-functional teams; integratepreclinicalinsights (targetselection, pharmacology, in vivo/in vitro data) into early clinical plans and seamless transitions to late phasedevelopment. Contribute to regulatoryinteractions and documentation (e.g., CTAs, INDs, safetyupdates, annualreports). Advance the development and validation of nonclinical and surrogateendpoints (includingimaging and biomarkers). Represent TSCD internally and externallythrough presentations, publications, and scientific forums; engagewithexternal experts and translate insightsintostrategy and study design. Helpevolvetrial operations and site engagement to improve speed, quality, and inclusivity in early studies. Collaborateacross CVRM on programs in heartfailure, type 2 diabetes, obesity, and metabolicdysfunction-associatedsteatohepatitis, given theirintersectionwithkidneydisease. Qualifications MD, MBBS or MD/PhD with clinical or research expertise in in the treatment of kidney diseases. Minimum of 1 year of clinical research in academia and/or the pharmaceutical/biotechnology industry. Experience designing, executing, monitoring, interpreting, and overseeing safety in early clinical and translational trials preferred. Strong command of biomarkers, surrogateendpoints, and biostatistics, supported by a robust publication record. Well developed interpersonal skills, effective teamwork, and the ability to engage stakeholders effectively across functions, geographies, and disciplines. Why AstraZeneca? Here, we need leadership at every level - Physicians who not only have clinical and scientific expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences. With that kind of remit comes great responsibility. We truly believe that everyone contributes with an outstanding set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution. 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. The Medical Director will be focused onKidney Diseaseand related conditions that impact kidney function. In this role, you will have the opportunity to work at the forefront of early clinical and translational research within CVRM. In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline of both small and large molecules in numerous active clinical programs. About the Team Who We Are In the Cardiovascular, Renal & Metabolism (CVRM) Translational Medicine & Clinical Development (TSCD) department, we are investigating the underlying factors contributing to CVRM disease progression using advanced scientific methodologies and data‑driven drug discovery. In this context, we are evaluating a wide range of different drug modalities from our rich CVRM portfolio of compounds across kidney disease patient populations. TSCD is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies and accelerating human target validation while collaborating closely with our late‑phase clinical development and regulatory colleagues who guide our pivotal phase 3 clinical studies. #J-18808-Ljbffr
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Hartford, United Kingdom ASTRAZENECA UK LIMITED Full timeA major pharmaceutical company in the United Kingdom is seeking a Medical Director to oversee early Phase I-II clinical trials focused on kidney disease. The ideal candidate will have recent clinical research experience, an MD or MD/PhD, and a strong background in clinical trials and regulatory documentation. Collaboration within a cross-functional team is...
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