Associate Director, Clinical Safety

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Responsibilities:

* Oversee clinical safety case management and aggregate reporting responsibilities at a
program level;
* Maintain relationships with clients and internal stakeholders by providing expert safety
knowledge;
* Provide safety review of clinical study documents, including protocols, study reports, and
marketing application components;
* Identify and manage process improvements, SOP updates, and training initiatives;
* Act as an internal and external advisor on safety related matters;
* Identify and manage process improvements, SOP updates and training initiatives;
* Manage various levels of employees; ​and
* May be responsible for other projects and responsibilities as assigned.

Qualifications:

* Master's degree and 5 years of clinical safety experience or Bachelor's degree and 8 years of
clinical safety experience; 
* Safety experience in a leadership position at a CRO;
* Responsible for departmental hiring, training, management, and evaluation of Clinical Safety
employees and other support personnel;
* Directly manages other Clinical Safety Coordinators and Managers in development of safety
plans, Standard Operating Procedures, guidelines, and narratives, and
* Bilingual Japanese and English.
			

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