Executive Director, Clinical Development & Medical Monitoring
About the Company
Innovative developer of universally implantable bioengineered human tissues for medical treatment
Industry
Biotechnology
Type
Public Company
Founded
2004
Employees
51-200
Categories
Specialties
About the Role
The Company is seeking an Executive Director for Clinical Development and Medical Monitoring. The successful candidate will be responsible for leading and overseeing the clinical development strategy, global clinical trials management, and CRO partnerships. This role requires a strong background in clinical trials, and the ability to influence and negotiate with both internal and external stakeholders. The Executive Director will be a key member of the CMO leadership team, providing medical oversight, and ensuring that clinical studies align with the strategic plans of the organization. Essential functions include developing and executing the clinical development plan, managing the clinical development budget, and representing the company at various professional events. Applicants must have an MD with a minimum of 7-10 years' of relevant pharma experience, and a strong knowledge of ICH/GCP/FDA and other country-specific regulations. The role also involves personnel management, including recruitment, retention, and performance management of the clinical team. The ideal candidate will have a background in the pharmaceutical industry drug/biologic development process, and experience with both sponsor and CRO perspectives. The Executive Director will also be involved in post-approval clinical studies, and must be able to effectively collaborate with regulatory, quality, medical affairs, and commercial teams. Vascular experience is preferred, and the candidate should be adept at leading discussions on strategy and policy with the executive management team.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions
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