Global Clinical Program Lead, CVRM

Role Summary

Global Clinical Program Lead, CVRM, responsible for the design, conduct, monitoring, data interpretation and reporting of clinical trials to determine benefits and risks of the compound and support the intended label indication globally. Operates in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements, while upholding high ethical standards.

Responsibilities

• Medical expert accountabilities: Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study; deliver medical information and clarifications to regulators, ethics committees, marketing companies, and investigators/sites.

• Trial Conduct And Hands-on Delivery Accountabilities: Be accountable to the Global Clinical Head or delegate for the medical aspects and designs of studies; drive decisions within Study Team remits, solve medical issues, ensure medical and ethical components of studies including patient safety in compliance with GCP; deliver clinical components of study documents; oversee safety surveillance and data querying; provide medical leadership for investigator meetings and national activities; approve the Clinical Study Report with the GCH.

• Messaging And External Impact Accountabilities: Maintain understanding of new and emerging medical developments globally; collaborate with international colleagues and alliance partners on development initiatives and regulatory issues; apply AstraZeneca’s strategic intent with partners, authorities, payers, opinion leaders, prescribers, and consumers; guide investigator-initiated trials with regional marketing companies.

Qualifications

• Required: Graduate of a recognized school of medicine with an MBBS, MD, or PhD/PharmD in a scientific discipline or Pharmaceutical Medicine; 3+ years of clinical research expertise in study design, protocol development, monitoring, and reporting of clinical trials; good knowledge of biostatistics, global regulatory environment, and pharmacovigilance; demonstrated partnership and collaboration skills with cross-cultural communication; strong presentation and effective communication skills.
• Preferred: Good general medical knowledge preferably in cardiology or metabolic disease; 3–5 years in the pharmaceutical industry with understanding of R&D milestones and factors influencing drug development.