Oversight of medical and ethical components of studies including patient safety in compliance with GCP
Deliver all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
Conduct 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 escalation to the GCH/Global Safety Physician when needed
Medically accountable for international investigator meetings, and support Marketing Companies in national activities
Approve, with the GCH, the Clinical Study Report; including preparation and production (Introduction, Results, Discussion)
Messaging and external impact accountabilities
Maintain a high degree of understanding and awareness of new and emerging medical developments, globally
Apply strategic intent when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
Provide guidance for investigator-initiated trials in collaboration with regional marketing companies
Basic Qualifications
Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree with specialty or experience in the Cardiovascular, Renal or Metabolism (including obesity, diabetes, MASH) therapeutic areas,
3+ years of pharmaceutical industry experience OR 3+ years of clinical research experience in the academic or clinical practice setting
Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
Fluent in oral and written English, with good presentation skills and effective communication
Desired Qualifications
Clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
Credibility in scientific and commercial environments
The annual base pay for this position ranges from $241,613 – $362,420 USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.
Join us in our unique and bold world.
Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
