Title Senior Clinical Scientist  About the Organization My company shares my passion for helping to improve human health around the world." "This is My MedImmune." Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.   Description 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   Position Requirements 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.   Educational Requirements 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 and effectively manage clinical trials and protocol development plans, preferably in the therapeutic area of the position. Key Skills: Demonstrated leadership and ability to work in cross-functional teams and with individuals. Global pharmaceutical experience is desired. Demonstrated ability to develop and manage/execute clinical research protocols. Effective verbal and written communication skills in relating to colleagues and associates at all levels both inside and outside the organization. Company Info None Specified  Company Info None Specified  This position is currently accepting applications.

 

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