Senior Director, Global Clinical Program Lead

As aSenior Director Global Clinical Program Lead youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives.The successfulStudyand ProgramClinical LeadinLate PhaseCVRM (Cardiovascular Renal and Metabolic diseases)will be responsible for the design conduct monitoring data interpretation and reporting of 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/orLiver Disease) 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

• Often works as a Global Clinical Head (GCH) delegate across several studies (e.g.apaediatricprogramme or a set of mechanistic / differentiating studies)

• Can be the clinical representative onindicationGlobal Product Teams and/or other sub-teams

• Has the knowledge to work across projects with afast learningcurve when moving into new disease area

• 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

• 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

• 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

• Accountable for building trustworthy relationships with steering committees/executive committees with AROs/CROs

• Maintains strong networks globally with KEEs prescribersregulatorsand payers

Requeriments

• 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

• 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

• Proven teamwork and collaboration skills

• Fluent in oral and written English

• Good presentation skillsand effective communication

• 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 in nephrology cardiologymetabolicor NASH

• Preferably 3-5 years in the pharmaceutical industry with anunderstanding of 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

• Education in Pharmaceutical Medicine

• Experience from different organizations

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.

The annual base pay for this position ranges from 288059.20 - 432088.80 SD Annual . Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.