Apply Now Job ID R-331451 Date posted 03/07/2019 Job Description Summary Job Description
The Clinical & Human Factors Program Leader (CHF-PL) is an integral position within the BDM-PS Clinical Development & Human Factors group within the Medical Affairs Department of BD Pharmaceutical Systems.
The CHF-PL has responsibility for generation of evidence supporting claims for BDM-PS products.
He/she is responsible for developing, supervising, executing and reporting of studies (clinical trials and Human factors studies in compliance with BD policies and procedures, to contribute to Medical Devices development. Participate in core teams to represent Medical Affairs in development phases when a study is in preparation.
Responsibilities for managing studies for the allocated products under development includes the following:
- Writing and updating the Clinical Development Plan (CDP)
- Contributing to task analysis, use FMEA, IFU building and validation
- Contributing to developing evaluation of BD products (methods and capabilities) to assess end-users acceptance, preference and willingness to adopt the medical device
- Establishing an appropriate budget and timeline for the study with input from the corresponding project core team
- Establishing investigational products specifications for HF studies in collaboration with R&D and the Laboratory (externally or internally) and supervising the preparation of the corresponding products on time and in compliance with defined budget
- Writing/reviewing study documents, as needed such as protocol, CRF, consent form, session guide, database, clinical study report
- Completing final study report and closing of study file, contributing to publication writing
Clinical studies may range from simulated use studies (employing a patient or health care worker to use the device in a simulated environment; e.g. Human Factor studies) to complex studies in human subjects that may include drug/device combinations.
Represents Medical Affairs in several core teams dedicated to new product development, sustaining engineering and innovation.
- Prepares and delivers presentations covering relevant Medical Affairs information (functional capabilities and clinical and HF study data) to customers during TC and face to face customer meetings.
It is expected that the CHF-PL acts as a leader of the Medical Affairs department, and mentors other individuals formally or informally. The CHF-PL is expected to set an example with respect to work ethic, maturity, and adherence to Regulations and Guidelines, industry best practices, and BD guiding principles.
Up to 15% domestic and international travel may be required.
- Masters or PhD in Human Factors, Biological Sciences, or PharmD a plus
- 2+ years of experience performing Human Factors Studies, within the Pharmaceutical or the Medical device industry, with good understanding and knowledge of Medical device environment (including design control) is a must.
Knowledge and Skills:
The candidate should be an expert in study design and protocol development, and should be capable of critically evaluating protocols and have the ability to identify potential issues with the study design or implementation plan that might confound the results; he/she should also be conversant with statistical methods (understanding of main statistical methods used in C&HF trial analyses).
The successful candidate should have demonstrated ability in project management, particularly in effectively managing programs across reporting lines and:
- Acquire quickly an advanced knowledge of BD products and specific legislations (e.g. in the context of medical devices and Human Factors environment)
- Possess excellent interpersonal skills, including the ability to perform well in a highly matrixed environment, and serve as an effective member of highly functioning multidisciplinary teams
- Demonstrate fluency in written and verbal English, be highly organized, dynamic, confident, energetic, creative, pro-active, and open to new experiences and ideas. Ability to communicate and work with global teams. Fluency in French is a plus.
- Demonstrate proficiency in using Word, Excel, Powerpoint, Microsoft project.
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