Global Development Medical Director

AstraZeneca•Gaithersburg, MD

5d•$249,827 - $374,740•Hybrid

About The Position

AstraZeneca is seeking a passionate Global Development Medical Director to join their team in Gaithersburg, MD. This role is crucial in channeling scientific capabilities to positively impact patients' lives. The successful candidate will be a Study Clinical Lead in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases), responsible for the design, conduct, monitoring, data interpretation, and reporting of clinical trials. The goal is to ensure that clinical data accurately determine the benefits and risks of compounds, supporting intended label indications and global market pricing. The individual must operate with the highest ethical standards, adhering to internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements. AstraZeneca emphasizes a collaborative and inclusive environment where employees can be their authentic selves, offering amenities like gym access, after-work events, lunch & learns, and a sustainable working environment.

Requirements

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 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
A clear demonstration of: Leadership qualities, with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting
AstraZeneca values and behaviors
Agile responsiveness to scientific data
Credibility in scientific and commercial environments

Nice To Haves

Good general medical knowledge preferably in nephrology or NASH
An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development
An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements

Responsibilities

Provides strategic medical and scientific knowledge (Cardiovascular, Renal, and/or NASH) 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.
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 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 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.