Study Clinical Lead

As aStudy Clinical Leadyoullplay a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives.The successfulStudy Clinical LeadinLate PhaseCVRM (Cardiovascular Renal and Metabolic diseases)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 willoperateaccording to the highest ethical standards in compliance with internal SOPs local regulations lawsGood Clinical Practiceand regulatory requirements.

Responsibilities

• Provides strategic medical and scientific knowledge (Cardiovascular RenalMetabolicand/orHepatic Diseases) and supports the design initiation executioncompletion and interpretationof a clinical study

• Is accountable for study designs

• Is accountable to deliver medical informationanswers and clarificationsto Regulators Ethic Committees Marketing CompaniesInvestigators/Sites

Trial conduct and hands-on delivery accountabilities

• Is accountable to the Global ClinicalHead(GCH) or delegate for the medical aspects and designs of studies

• Is responsible fordriving decisions within Study Team (ST) remits together with other ST membersand for solving medical issues in the study team

• Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP

• Is accountable for delivery ofthe clinical components ofall relevant study documents (e.gProtocolAmendmentsStatistical Analysis Plan InformedConsentForm CaseReportFormsand Safety andRisk-BasedMonitoringPlans)

• Is accountable forensuring thatsafety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting thequerying ofmissing/unclear datathereviewofblinded safety dataandtheescalationtotheGCH/Global Safety Physician when needed.

• Is medically accountable for international investigator meetings and supportsMarketing Companies (MC)innational activities

• Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction Results Discussion).

• Is accountable for 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

• May be accountable toGCH(or delegate) andleadership foridentifyingrisks and proposing mitigation strategies to deliver successful Phase IIIIIIV or LifeCycleManagementstudies

Scientific medical analytical accountabilities

• Stays updated onrelevantscientificliterature

• Delivers analyses of clinical data in a balanced statistically sound fashion to drive interpretations and further idea generation

• Serves as a source of medicalexpertisefor the Product Team in analyses and interpretation of medical data

Messaging and external impact accountabilities

• Maintains a high degree of understanding and awareness on new and emerging medical development globally.

• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues

• Applies strategic intent of AstraZeneca when working with Alliance partners Regulatory Authorities payers opinion leadersprescribersand consumers of AstraZeneca products

• Able to provide guidance forinvestigator-initiatedtrials in cooperation with regional marketing companies

MinimumRequirements

• Graduate of a recognized school of medicine with an M.B.B.S. M.D. degree or equivalentand/oragraduate of a scientific doctorate(e.g.PhD or PharmD) or equivalentin a scientific discipline or Pharmaceutical Medicine

• Proven teamwork and collaboration skills

• Fluent in oral and written English

• Good presentation skillsand effective communication

A clear demonstration of:

• Leadership qualitieswith particular focus on collaborative working skillstrustand openness irrespective of cultural setting

• AstraZeneca values and behaviors

• Agile responsiveness to scientific data

• Credibilityin scientific and commercial environments

Desired Experience:

• Good general medical knowledge preferably inendocrinologynephrologyorMASH

• Experience of clinical research and clinicalexpertisein one of our core therapy areas are valued assets

• 3 years clinical researchexpertisein relevant therapy area in study design protocol developmentmonitoringand implementing clinical trialsinterpretingand reporting trial results

• Good knowledge of biostatistics global regulatoryenvironmentand pharmacovigilance

• An understanding of pharmaceutical industry R&D particularly of major clinical milestones and of the factors which influencedrug development

• An understanding of the interplay between clinical commercialobjectives drugsafetyand regulatory requirements

Why AstraZeneca

Here we need leadership at every level - leaders who not only have expertise but also the ability to build a case engage multiple partners and communicate effectively with different audiences. Early clinical development is at the forefront of discovery of new medicines for patients with high unmet need. With that kind of remit comes great responsibility. Your curiosity and passion for personal development combined with support from colleagues mentors and leaders will ensure you maximize your skills abilities and contribution. We offer a competitive salary and excellent benefits