AstraZeneca
Healthcare
StudyClinicalLead
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“Study Clinical Lead at AstraZeneca. Skills: Clinical trial leadership, Medical expertise, Study design. Provide strategic medical and scientific knowledge. Support design of clinical study”
What You'll Achieve.
Determine benefits and risks of compound; Allow for intended label indication; Allow for intended price in markets globally; Deliver successful Phase II, III, IV or Life Cycle Management studies
Industry & Context.
Solving medical issues; Identifying risks; Proposing mitigation strategies; Data-driven decision making
What They're Looking For.
Must Have
Graduate of a recognized school of medicine with an M. B. B. S. , M. D. degree or equivalent, Graduate of a scientific doctorate (e. g. PhD or PharmD) or equivalent in a scientific discipline or Pharmaceutical Medicine, Proven teamwork and collaboration skills, Fluent in oral and written English, Good presentation skills, Effective communication
Nice to Have
Good general medical knowledge preferably in endocrinology, nephrology, or MASH, Experience of clinical research and clinical expertise in one of our core therapy areas are valued assets, 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, Good knowledge of global regulatory environment, Good knowledge of pharmacovigilance, An understanding of pharmaceutical industry R&D, An understanding of major clinical milestones, An understanding of factors which influence drug development, An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements
What You'll Do.
Provide strategic medical and scientific knowledge
Support design of clinical study
Support initiation of clinical study
Support execution of clinical study
Support completion of clinical study
Support interpretation of clinical study
Accountable for study designs
Deliver medical information to Regulators
Deliver medical information to Ethic Committees
Deliver medical information to Marketing Companies
Deliver medical information to Investigators/Sites
Accountable for medical aspects of studies
Accountable for designs of studies
Drive decisions within Study Team remits
Solve medical issues in the study team
Accountable for medical components of studies
Accountable for ethical components of studies
Accountable for patient safety on study level
Accountable for delivery of clinical components of study
Accountable for ensuring safety surveillance on study level
Accountable for Adverse Events (AE)/ Serious AE reporting
Accountable for querying missing/unclear data
Accountable for review of blinded safety data
Accountable for escalation to GCH/Global Safety Physician
Medically accountable for international investigator meetings
Support Marketing Companies (MC) in national activities
Approve the Clinical Study
Prepare Clinical Study
Produce Clinical Study
Accountable for ST induction
Accountable for education of new members
Collaborate seamlessly with global colleagues
Identify risks for studies
Propose mitigation strategies for studies
Stay updated on relevant scientific literature
Deliver analyses of clinical data
Drive interpretations of clinical data
Generate further ideas
Serve as source of medical expertise for Product
Maintain understanding of new medical development
Maintain awareness of emerging medical development
Work with international colleagues on development initiatives
Work with external Alliance partners on development initiatives
Work with international colleagues on regulatory issues
Work with external Alliance partners on regulatory issues
Apply strategic intent of AstraZeneca with Alliance partners
Apply strategic intent of AstraZeneca with Regulatory Authorities
Apply strategic intent of AstraZeneca with payers
Apply strategic intent of AstraZeneca with opinion leaders
Apply strategic intent of AstraZeneca with prescribers
Apply strategic intent of AstraZeneca with consumers
Provide guidance for investigator-initiated trials
Cooperate with regional marketing companies
How You'll Work.
Team & Collaboration
Study Team members; Global colleagues; Product Team; International colleagues; Alliance partners; Regional marketing companies
Communication Scope
Good presentation skills; Effective communication; Medical information delivery; Guidance for trials
Process & Methodology
Study design, Protocol development, Monitoring, Implementing clinical trials, Reporting trial results, Risk-based monitoring, Mitigation strategies
Full Job Description
As a Study Clinical Lead, 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 (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 will operate according 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/or Hepatic Diseases) and supports the design, initiation, execution, completion, and interpretation of a clinical study * Is accountable for study designs * Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites **Tria l conduct and hands-on delivery accountabilities** * Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies * Is responsible for driving decisions within Study Team (ST) remits together with other ST members and 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 of the clinical components 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) * Is accountable for ensuring that safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE re
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