Global Clinical Program Lead, CVRM

AstraZeneca • Boston, MA

1d • $280,895 - $421,342 • Onsite

About The Position

At the cutting-edge of science, AstraZeneca is a place to rethink the future of medicine. For the industry, ourselves, and patients. Work on ground-breaking medicine development and be at the forefront of answering some of the most complex unmet patient needs. As a 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 successful GCPL in Late Phase CVRM 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 allow for the intended label indication 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. What you will do: Medical expert accountabilities Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study Be accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites Trial conduct and hands-on delivery accountabilities Accountable to the Global Clinical Head or delegate for the medical aspects and designs of studies Responsible for driving decisions within Study Team remits together with members and for solving medical issues in the study team Accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP 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) 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. Medically accountable for international investigator meetings, and supports Marketing Companies in national activities Approve (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion). Messaging and external impact accountabilities Maintain a high degree of understanding and awareness on new and emerging medical development, globally. Work with international colleagues and with external Alliance partners on development initiatives and regulatory issues Apply strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products Provide guidance for investigator-initiated trials in cooperation with regional marketing companies

Requirements

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree, and/or a graduate of a scientific doctorate (e.g. PhD or PharmD) 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
• Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
• Strong presentation skills and effective communication

Nice To Haves

• Good general medical knowledge preferably in cardiology or metabolic disease.
• Preferably 3-5 years in the pharmaceutical industry, with an understanding of R&D, particularly of major clinical milestones and of the factors which influence drug development

Responsibilities

• Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study
• Be accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites
• Accountable to the Global Clinical Head or delegate for the medical aspects and designs of studies
• Responsible for driving decisions within Study Team remits together with members and for solving medical issues in the study team
• Accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP
• 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)
• 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.
• Medically accountable for international investigator meetings, and supports Marketing Companies in national activities
• Approve (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).
• Maintain a high degree of understanding and awareness on new and emerging medical development, globally.
• Work with international colleagues and with external Alliance partners on development initiatives and regulatory issues
• Apply strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
• Provide guidance for investigator-initiated trials in cooperation with regional marketing companies

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage
• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees