Clinical and Human Factors Program Manager Job Description Summary
Job Description Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Clinical & Human Factor Program Manager (CHF-PM) is part of the Clinical & Human Factor group within the Medical Affairs Department of BD Pharmaceutical Systems, ADDS Platform. The CHF-PM has responsibility for generation of evidence supporting claims for Wearable Injectors.
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 product development and during the product life cycle. He/she will represent Medical Affairs internally (core team level) and externally (customer communication).
Writing and updating robust Integrated Medical Plan for assigned product (Wearable Injectors).
Building study design.
Contributing to task analysis, use FMEA, DFU building and validation.
Contributing to developing evaluation of BD products (methods and capabilities) to assess usability, acceptance, preference.
Establishing an appropriate budget and timeline for the study with input from the corresponding project core team.
Manage suppliers and other internal/ external parties: Global Clinical Development group.
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.
Assure IRB approval if needed and applicable.
Maintaining study documentation into the central study file.
Supervising the interface with data management and statistics in developing case report forms, managing data cleanup, and analyzing study data.
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.
The CHF-PM interacts with product core teams and members:
Represents Medical Affairs in several core team and cluster handling new product development.
Is accountable to the team leader for deliverables.
Leads the overall planning, leadership and execution of all activities.
Provides work direction to the product safety and clinical development extended team members with regards to the project.
Estimates resources requirement and identifies resources in conjunction with functional managers.
Ensures deliverables produced meet the appropriate quality standards.
Communicates progress and facilitates decision making with the core team and Medical Affairs function.
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 The CHF-PM is responsible for assuring that study is conducted with HF guidelines (HF studies) and all National and Local Regulations.
The CHF-PM participates in establishment and updating of the SOPs related to the C&HF development activities.
Attend and complete assigned training courses concerning medical devices and human factors.
It is expected that the CHF-PM acts as a leader of the department, and mentors other individuals formally or informally.
Set an example with respect to work ethic, maturity, and adherence to Regulations and Guidelines, industry best practices, and BD guiding principles.
Contribute to cross department and corporate initiatives, and to share their expertise.
May be required to travel intermittently to achieve his/her routine responsibilities. He/she must be available for limited domestic or international travel as-needed basis within any C&HF study (mainly for study conduction in Europe, in USA, and potentially in Asia). Travel should not exceed 25 percent of his/her time.
Education and Experience Requirements
Masters or PhD in Biological Sciences, or PharmD highly preferred.
(Bachelor's in Biology or Life Science with 20+ years experience may be considered in lieu of Masters or PhD)
Experience 4-6 years of clinical experience within the Pharmaceutical or the Medical device industry for PhD, PharmD or 10 years of clinical experience for MS, with good understanding and knowledge of Medical device environment (including design control); regarding applicable Quality / Regulation, a good understanding and operational knowledge of national regulations and a good understanding of international regulations are needed.
Knowledge and Skills
The CHF-PM 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:
Anticipate and prevent issues in studies, propose potential solutions.
Acquire quickly a sophisticated 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 proficiency in written and verbal English, be highly organized, dynamic, confident, energetic, creative, pro-active, and open to new experiences and ideas.
Demonstrate proficiency in using Word, Excel, Powerpoint, Microsoft project.
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.