Global Development Medical Director

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 249,827 - 374,741; Full time

Job summary

AstraZeneca is seeking a Global Development Medical Director to lead late‑phase CVRM studies, guiding design, conduct, data interpretation, and reporting to determine benefits and risks for global indications. You will ensure compliance with GCP, SOPs, and regulatory requirements across trials.

You will provide strategic medical input, solve issues with study teams, and collaborate with global colleagues to advance Phase II–IV and lifecycle management studies, while delivering high-quality

Qualifications

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. or equivalent, and/or a scientific doctorate (e.g. PhD or PharmD).
• Proven teamwork and collaboration skills.
• Fluent in oral and written English.
• Good presentation skills and effective communication.

Responsibilities

• Provides strategic medical and scientific knowledge and supports design, initiation, execution, completion, and interpretation of a clinical study.
• Is accountable for study designs and delivery of clinical study documents.
• Communicates medical information to Regulators, Ethics Committees, Marketing Companies, Investigators.

Skills

Teamwork

English fluent

Presentation skills

Communication

Leadership

Agile mindset

Credibility

Education

MD/MBBS or equivalent

PhD/PharmD or equivalent

Job description

As a Global Development Medical Director, 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/orHepatic Diseases) and supports the design, initiation, execution,completion, and interpretationof a clinical study
• Is accountable for study designs
• Is accountable to deliver medical information,answers,and clarificationsto Regulators, Ethic Committees, Marketing Companies,Investigators/Sites

Trial conduct and hands‑on delivery accountabilities

• Is accountable to the Global ClinicalHead(GCH) or delegate for the medical aspects and designs of studies
• Is responsible fordriving decisions within Study Team (ST) remits together with other ST membersand 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 ofthe clinical components ofall relevant study documents (e.gProtocol,Amendments,Statistical Analysis Plan, InformedConsentForm, CaseReportForms,and Safety andRisk-BasedMonitoringPlans)
• Is accountable for ensuring thatsafety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, thequeryingofmissing/unclear data,thereviewofblinded safety data,and theescalationtotheGCH/Global Safety Physician when needed.
• Is medically accountable for international investigator meetings, and supportsMarketing Companies (MC)innational 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 toGCH(or delegate) andleadership foridentifyingrisks and proposing mitigation strategies to deliver successful Phase II,III,IV or LifeCycleManagementstudies

Scientific medical analytical accountabilities

• Stays updated onrelevantscientificliterature
• Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
• Serves as a source of medicalexpertisefor the Product Team, in analyses and interpretation of medical data

Messaging and external impact accountabilities

• 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,prescribersand consumers of AstraZeneca products
• Able to provide guidance forinvestigator-initiatedtrials in cooperation with regional marketing companies

Minimum Requirements

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent,and/oragraduate of a scientific doctorate(e.g.PhD or PharmD) or equivalentin a scientific discipline or Pharmaceutical Medicine
• Proven teamwork and collaboration skills
• Fluent in oral and written English
• Good presentation skillsand effective communication

A clear demonstration of:

• Leadership qualities,with particular focus on collaborative working skills,trustand openness, irrespective of cultural setting
• AstraZeneca values and behaviors
• Agile responsiveness to scientific data
• Credibilityin scientific and commercial environments

Desired Experience:

• Good general medical knowledge preferably inendocrinology,nephrology,orMASH
• Experience of clinical research and clinicalexpertisein one of our core therapy areas are valued assets
• 3+ years clinical researchexpertisein relevant therapy area in study design, protocol development, monitoringand implementing clinical trials, interpretingand reporting trial results
• Good knowledge of biostatistics, global regulatoryenvironmentand pharmacovigilance
• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influencedrug development
• An understanding of the interplay between clinical, commercialobjectives, drugsafetyand regulatory requirements

Why AstraZeneca?

Here, we need leadership at every level - leaders who not only have expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences. Early clinical development is at the forefront of discovery of new medicines for patients with high unmet need. With that kind of remit comes great responsibility. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution. We offer a competitive salary and excellent benefits.

The annual base pay for this position ranges from 249,827.20 - 374,740.80 USD Annual. Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday and leaves), as well as health, dental and vision coverage in accordance with the terms of the applicable plans.

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.