Director of Clinical Affairs

    Position Summary:   Coordinates and executes all activities related to clinical studies for ongoing development projects.  In cooperation with Regulatory Affairs, ensures timely clinical development and coordinates all non-clinical studies in accordance with requirements for US and foreign regulatory submissions and registrations for new in-vitro diagnostics devices.


 


Principle Duties:


· Plans, develops and monitors clinical trial projects, including clinical protocols, case report forms and clinical trial budgets.


· Identifies clinical sites and/or clinical sample vendors and prepares clinical investigator and other agreements as required.


· Monitors outside clinical research studies to ensure the studies are being executed in accordance with protocol and federal regulatory guidelines.


· Reviews, evaluates and compiles files and reports for direct inclusion in submissions including 510K and PMA applications and foreign registration documentation.


· As required, interacts with Scientific Advisory Board members and outside consultants on the design of clinical trial protocols, including case report form design.


· In cooperation with the CSO and Regulatory Affairs personnel, interacts with regulatory agency personnel in order to obtain buy-in on clinical trial study design.


· In cooperation with the CSO and Regulatory Affairs personnel, interacts with regulatory agency personnel in order to expedite approval of pending applications.


· Plans and develops clinical research projects, including protocols, databases, and budgets.


· Manages clinical research projects and grants to outside academic collaborators.


· In cooperation with the CSO, Regulatory Affairs personnel, SAB members, and clinical investigators, analyze data from clinical development and/or research studies for inclusion in regulatory submissions, meeting abstracts and posters, and manuscripts.


· Provides Clinical support for all projects as needed.


· Responsible for the development of clinical budgets and timelines.


· Other duties as assigned.


 


Job Specifications (Skills, knowledge, special training, certification, license requirements):


· Thorough knowledge of the clinical development process, especially as it relates to diagnostics.


· Thorough knowledge of clinical assay development with particular emphasis on non-clinical studies required for regulatory submissions.


· Knowledge of IVD regulations, the FDA, CE Marking and other foreign registration procedures.


· Knowledge of GCP and GMP.


 


Principle Relationships:


Inside the Company: All levels of personnel.


Outside the Company:  Clinical investigators, Regulatory agency personnel, contract research organizations and consultants as required. 


Supervisory Responsibilities:  Clinical Development Director, Clinical Affairs Assistant.


 


 


 


Education and Work Experience Required:


· Ph.D. in Life Sciences or related discipline or minimum of 10 years clinical research and development experience required.


· Must have at least 5 years experience in all aspects of IVD clinical trials development and management. Experience with/knowledge of the preparation of 510K’s and/or PMA’s required.


· Demonstrated excellence in writing.


· Demonstrated interpersonal skills a must.


· Demonstrated ability to lead and take charge of clinical projects a must.


· Experience in the pharmaceutical, biotech, diagnostics or related business is a necessity.


 


Essential Job Functions (as defined under the American’s with Disabilities Act):


· Ability to effectively utilize a computer.


· Ability to communicate with all levels of staff and outside personnel.


· Ability to work in a high pressured, deadline oriented environment.


· Good communication and negotiation skills.


· Can work independently and in a team setting.


 





1. PhD is not a requirement - BA/BS is fine. We will value experience more.


2. Successful history/experience with Clinical Trial/Study Management for is a MUST. (We have 3 trials going on right now and this person will be jumping right in to it, so we really need someone who knows what they are doing.)


3. We will consider relocating someone if that is needed. An appropriate package will be determined if we decide to hire a person who needs it.