Medical Director, Clinical Development

4 weeks ago

Boston, United States Alexion Pharmaceuticals, Inc. Full time

Position Summary

* The medical director contributes to a cross-functional team in the design and execution of one or more clinical studies and provides input to the clinical development plan for an investigational product.

Principal Responsibilities

* Monitor the completeness and quality of safety and efficacy data
* Communicate with investigators and other stakeholders to assure appropriate subject enrollment and safety oversight
* Provide medical review of study-related documents, such as the protocol, informed consent, clinical study report, safety narratives, laboratory manual, and pharmacy manual
* Provide medical oversight for investigator meetings and site initiation visits
* Investigate protocol deviations to determine whether intervention is required
* Respond to questions from health authorities and institutional review boards/ethics committees
* Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan

Qualifications

* Experience in industry or academic clinical or basic science research

Education

* MD, DO, or equivalent with post-graduate training from an accredited institution
* Subspecialty training and board certification are highly desirable but not required

Competencies

* Fluent in written and spoken English language
* Able to utilize software and operating systems required for training, data management, and presentations
* Scientific and statistical background to interpret and communicate complex data sets

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 authorization and employment eligibility verification requirements.

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