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Senior Director, Global Clinical Program Lead
AstraZenecaSenior Director, Global Clinical Program Lead directing global clinical studies in cardiovascular, renal and metabolic diseases for AstraZeneca. Ensuring ethical standards and compliance in clinical research.
Core Competencies
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Demonstrates expertise in clinical research, including study design, protocol development, and regulatory compliance, with a strong focus on patient safety and ethical considerations. Possesses advanced knowledge in Cardiovascular, Renal, Metabolic, and Liver Disease, along with effective communication and leadership skills to collaborate with diverse teams and stakeholders.
ATS Keywords
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Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Provides strategic medical and scientific knowledge (Cardiovascular, Renal, Metabolic, and/or Liver Disease) 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
- Often works as a Global Clinical Head (GCH) delegate across several studies (e.g. a paediatric programme, or a set of mechanistic/differentiating studies)
- Can be the clinical representative on indication Global Product Teams and/or other sub-teams
- Has the knowledge to work across projects, with a fast learning curve when moving into new disease area
- 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 reporting, the querying of missing/unclear data, the review of blinded safety data, and the escalation to the GCH/Global Safety Physician when needed.
- Is medically accountable for international investigator meetings, and supports Marketing Companies (MC) in national 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 to GCH (or delegate) and leadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or Life Cycle Management studies
- Stays updated on relevant scientific literature
- Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
- Serves as a source of medical expertise for 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, prescribers and consumers of AstraZeneca products
- Able to provide guidance for investigator-initiated trials 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, regulators and payers
Requirements
What you’ll need- Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent, and/or a graduate of a scientific doctorate (e.g. PhD or PharmD) or equivalent in a scientific discipline or Pharmaceutical Medicine
- 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, global regulatory environment and pharmacovigilance
- Proven teamwork and collaboration skills
- Fluent in oral and written English
- Good presentation skills and effective communication
- Leadership qualities, with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting
Benefits
Comp & perks- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage