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Assoc Director/Director Early Clinical Development Oncology

Plats Gaithersburg, Maryland, USA Jobb-id R-050154 Datum inlagd 05/03/2019

If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

We have a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Major Duties and Responsibilities (including supervising others):

The Early Clinical Development Scientist will be responsible for preparation of key product documentation to include protocols, Clinical Development plans, and regulatory submission documents.This role will also develop key elements of data review plans, along with performing medical data review during study execution.

This role will focus on less complex studies relative to the entire portfolio.This will include studies with fewer study arms, shorter study durations and lower analytical complexity.

The individual has full Clinical Scientist responsibility for his/her studies and will review key document plans, scientific data and analysis and recommendations with their direct management and/or mentor.

Responsibilities

Perform medical and scientific data review to ensure integrity of accruing clinical study data, and to characterize and understand emerging trends in safety and efficacy.

Such reviews include:

oBlinded Safety Review

oSerious Adverse Events (SAEs)

oPhysical Exam, Medical history and concomitant medication

oCouncil for International Organizations of Medical Sciences (CIOMS) Review

oNarrative Reviews

oProtocol Deviation reviews

oCoding reviews

oOther medical/scientific data reviews and analyses for clinical support, as appropriate and as needed

·Develop and review of key documents (i.e. Clinical Study Protocol, Investigator’s Brochure, Pediatric Investigational Plan, Periodic Safety Reports, or documents of equivalent complexity and scope)

·Prepare Clinical Study Reports and provide input into communication and publication development

Collaborations

·Collaborate with clinical statistics and data management to ensure that data are collected, reviewed, and summarized in a scientifically valid manner to evaluate study endpoints

·Collaborate with translational science to optimize approaches to understand mechanism of action and dose-response, and to develop biomarker and companion diagnostic strategies.

·Coordinate with patient safety and pharmacovigilance personnel to ensure that emerging safety signals are appropriately identified, mitigated, and communicated.

Education:

PhD/PharmD in health science field is preferred or other advanced scientific degree with relevant work experience

Experience Required:

·7 plus years post- PhD in drug development, preferably translational sciences / toxicology / clinical operations, or other strong scientific research background.

·3 years post PharmD degree, in drug development, preferably translational sciences / toxicology / clinical operations, or other strong scientific research background.

·Masters degree with 11+ years in drug development, preferably translational sciences / toxicology / clinical operations, or other strong scientific research background.

Special Skills/Abilities

Demonstrated ability to work in cross-functional teams and with individuals.Effective verbal and written communication skills in relating to colleagues and associates at all levels both inside and outside the organization. Demonstrated excellent data analysis, scientific writing and presentation skills. Evidence of ability to rapidly learn clinical research and study responsibilities is required.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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