Senior Clinical Scientist - Inflammation

Organization
AstraZeneca Pharmaceuticals
Job Location
Gaithersburg, MD
Salary
Benefits
Job Description

The Senior Clinical Scientist will provide scientific and clinical input to all aspects of late stage product development and marketing across the entire product life-cycle. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of INR products in late stage development. The Senior Clinical scientist ensures that the project team seeks input from the appropriate functional experts and coordinates these activities in support of clinical studies and programs. The objectives of the Senior Clinical Scientist will be set by the Group Director in agreement with the Medical Science Director(s). The current role will have a special focus on late stage clinical trials within the respiratory and inflammation therapy area where the Senior Clinical scientist will work in close collaboration with the study team physician with all aspects of scientific input and clinical data quality.

Major Responsibilities

In collaboration with study team physician:

* Organize and contribute to
* Study set-up with special focus on ensuring high quality data collection in the Web Based Data Capture system in line with study protocol
* Investigators' and monitors' meetings
* Data Safety and Monitoring Board (DSMB) charter, routines and data flow
* Other safety and clinical teams as appropriate

* Medical monitoring of trials
* Site interaction with documentation and training
* Ensure fit for purpose reports are available for Medical Monitoring
* regarding I/E criteria and other protocol related issues
* Support study team physician with safety reviews

* Lead development of a Data Review Plan
* Prepare and deliver reports for Study Team Physician on important aspects of the study protocol (i.e important endpoints)- including Data Review Tool
* Prepare and deliver updates to the core Clinical Study Team
* Prepare and deliver updates to the International Coordination Investigator (ICI) and/or Data Safety Monitoring Board
* Review of Tables, Figures and Listings, Blind Data Review and mock Clinical Study Report

* Supervise/mentor and advise study team members in therapeutic area training, as well as in the planning, conduct, data review, data cleaning and signal detection

* Adheres to high quality study design & interpretation processes and standards; supports adherence of design & interpretation working groups to AZ standards.
* Proactively integrates functional experts into design and interpretation activities.
* Achieves high quality scientific and or clinical interpretation of data generated from executed studies.
* Provides bench-marking efficacy and safety data as requested by the project to contribute to the design of phase III and post-phase III studies
* Supports and, as delegated by the MSD, represents AstraZeneca in interactions with key customers (i.e., internal stakeholders, key opinion leaders, regulators, payers, prescribers, patients).
* Assumes other duties as assigned by the Group Director.

Key accountabilities:

* Support Study Team Physician and Clinical Operations as requested by clinical project team (e.g., training of CRO and providing ongoing guidance to clinical operations, including data management, team to ensure full understanding of study protocol and for clinical site identification, start-up activities, subject recruitment, presentation at investigators meetings, etc.)
* Lead and participate in acitivities that ensure quality, consistency and integration of clinical study related deliverables
* Ensure medical/scientific input to TA standards team

Requirements:
Minimum Requirements:

Education and Experience:

* Scientific doctoral level degree (e.g. PhD or PharmD) or relevant equivalent clinical qualification or other relevant university degree with extensive experience from clinical development.
* Demonstrated leadership experience and expertise in clinical care, academia and/or the pharmaceutical industry.
* Five or more years of relevant pharmaceutical industry experience (research and/or medical affairs) is required.
* Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results.
* Strong oral and written communication skills. Proven ability to work collaboratively in a cross-functional setting.
* Strong IT and technical skills
* Track record from support of clinical study teams in late phase development
* Ability to travel nationally and internationally.

Preferred Background:

* 8-10 years work experience with a focus in inflammation or respiratory disorders.
* Comprehensive understanding of data management and clinical analysis and reporting activities
* Demonstrated ability to interact effectively with internal senior leaders and external key opinion leaders is highly preferred.

Organizational Behavior:

* Acts Decisively
* Commitment to customers and integrity
* Strategic Leadership
* Drives accountability
* Works collaboratively
* Develops people and organisation

Customers:

Works with internal and external customers, including Clinical Study Teams, Clinical Project Teams, Global Product Teams, Therapy Areas, Global Marketing and Business Development, Regulatory, and FDA to accomplish tasks related to the product development, to improve clinical development processes, and to ensure satisfaction of these customers.

Reporting Relationship:

Direct Reports --none

Indirect Reports -- none

Requirements
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