Senior Clinical Scientist

Title: Senior Clinical Scientist
Location: MD Gaithersburg - Corporate Headquarters
Req: 02107

The Senior Clinical Scientist will work in collaboration with the Medical/Clinical Research personnel (Clinical Leader Medical Director) to assist in the preparation of Investigational New Drug Applications (INDs) Clinical Development Plans (CDPs) protocols and Clinical Study Reports (CSRs) and the execution of clinical trials. The Senior Clinical Scientist or Clinical Science Director may serve in various roles including membership on a clinical team and clinical project sub-teams may serve in leadership roles within these teams.
The Senior Clinical Scientist or Clinical Science Director will work in collaboration with the Medical/Clinical Research personnel to lead clinical scientific strategy in respiratory disease areas. This includes developing and delivering programmes of work to support projects or groups of projects with biomarkers and clinical measurements for proof of mechanism (PoM) Proof of Principle (PoP) and Proof of Concept (PoC) and to work globally across Medimmune and AstraZeneca to support the respiratory strategy with disease biomarkers for patient segmentation and personalised healthcare plans.

Basic Work

 Collaborate and leadMedical/Clinical Research personnel to:
o Medical monitoring of trials
 Site interaction with documentation
 Regard I/E criteria and other protocol related issues
 Medical Questions
 Unblinding requests
 Safety issues
o Data Review
 Safety
• Serious Adverse Events (SAEs)
• Blinded Safety Review
• Council for International Organizations of Medical Sciences (CIOMS) Review
• Narrate Reviews
• OSMB responsibilities
o Organize Participate in
• Study set-up
• Investigator meetings






o Establish and approve scientific methods for design and implementation of applicable clinical protocols data collection systems and final reports.
o Develop and review key documents to support the components of a regulatory submission.
o Review and interpret study results as appropriate.
o Prepare clinical publications or provide input into communication and publication development.
 Become familiar with the latest thinking regarding mechanism of disease diagnostic tests treatment drug development trends and regulatory requirements in assigned disease and therapeutic areas.
Work across functions (including Discovery and Clinical) to plan scope and deliver translational medicine plans for projects or groups of projects in early clinical development including biomarkers and clinical endpoints to enable decision-making for milestone investments. This will include identification of risks and mitigation plans resource and budget forecasts for plan(s) delivery.

Internal Collaboration

 To lead the delivery of projects and programs of work through:o Establishing links between company experts in relevant departments including regulatory bio-pharmaceutics discovery and pharmacology/toxicology sciences to initiate and expedite clinical studies.
O Managing the planning and forecasting of budget and resource to deliver projects and programs or work to time
o Collaborate with translational science to optimize approach to study target neutralization and understand mechanisms of action.
o Coordinate with pharmacovigilance personnel in developing the Benefit Risk Management Plan in conjunction with MedImmune’s Safety Monitoring Committee and other external groups as appropriate.
O Ensure communication input and alignment with global strategic plans across Medimmune and AstraZeneca of overall clinical development strategy and biomarker development for respiratory indications

External Collaboration

 Assist with the management of and input into Advisory Boards convened CDP as appropriate.
 Lead and plan conducting efforts to obtain external scientific and clinical validation of clinical research protocols.
 Establish links with outside experts to initiate and expedite clinical studies. May include seeking advice from KOLs regulatory pricing/reimbursement and market access experts.
Identify and manage external collaborations with key opinion leaders to support protocols and research activities supporting disease understanding clinical measurements biomarker development and mechanistic understanding.




Educations:
Educational Requirements QUALIFICATIONS/REQUIREMENTS
Education:
PhD or masters degree in heath science field PharmD MD or other relevant advanced degree in a health science field is preferred.

Work Experience/Skills:
Minimum: 6 years of progressively responsible clinical research experience or demonstrated ability to develop clinical research protocols a

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MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.