Clinical Program Development Jobs in Randolph, MA

As aSenior Director, Global Clinical Program Lead, you'll 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, laws,Good Clinical Practice,and regulatory requirements.

Responsibilities

• Provides strategic medical and scientific knowledge (Cardiovascular, Renal,Metabolic,and/orLiver Disease) and supports the design, initiation, execution,completion, and interpretationof a clinical study

• Is accountable for study designs

• Is accountable to deliver medical information,answers, and clarificationsto Regulators, Ethic Committees, Marketing Companies,Investigators/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.gProtocol,Amendments,Statistical Analysis Plan, InformedConsentForm, CaseReportForms,and 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 data,thereviewofblinded safety data,andtheescalationtotheGCH/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 II,III,IV 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 leaders,prescribersand 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, prescribers,regulatorsand payers

Requeriments

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent,and/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 development,monitoringand implementing clinical trials,interpretingand 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 qualities,with particular focus on collaborative working skills,trustand 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, cardiology,metabolic,or 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 288,059.20 - 432,088.80 SD Annual . Our positions offer eligibility for various incentives-an 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.