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Global Development Medical Director

AstraZeneca

MD, Gaithersburg, US$250k – $375konsite

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About this role

Do you have a passion for Science ? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Welcome to Gaithersburg, MD one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you…g ym access, after-work events, lunch & learns, bright and spacious environment, sustainable office working environment and networking events.

As a Global Development Medical Director in Gaithersburg, MD, 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/Accountabilities:

Medical expert accountabilities • 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

Trial conduct and hands-on delivery accountabilities • 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

Scientific medical analytical accountabilities • 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

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, prescribers and consumers of AstraZeneca products

• Able to provide guidance for investigator-initiated trials 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/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 b ehaviors

• Agile responsiveness to scientific data

• Credibility in scientific and commercial environments

Desired Experience: • 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 dr

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