Global Development Medical Director

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.

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Worksite address

gaithersburg, MD, 20883, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.