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Job Description Summary

Reporting to the WW Vice President, Medical Affairs (MA), BD Diagnostics- Preanalytical Systems this position is leading the PAS MA Laboratory Operations and Medical Affairs PLE team and is a member of the World Wide PAS MA Leadership Team and Global Clinical Council (GCC) Core Team. This position has the responsibility to provide medical, scientific, technical and laboratory customer-focused leadership and perspective, and is ultimately responsible for clinical study execution for all internal clinical studies throughout the BD PAS product life cycle (new product development, sustaining engineering and post market), data analysis and review, as well as for scientific integrity and clinical accuracy of all claims and communications made concerning these products globally. The individual will drive clinical trial excellence for BD sponsored and supported clinical studies (internal and external) ensuring clinically sound study designs and compliance to national and international ICH Good Clinical Practice (GCP) guidelines; will be responsible for review and approval of all clinical trial protocols and reports for safety and efficacy studies as well as post market studies. The individual will also be responsible for developing the post market study process and will drive compliance for global and regional post market studies. Directly reporting to this position is the Clinical Laboratory Manager, and the Senior Manager, Medical Affairs Product Life cycle Engineering Team.

Job Description

Primary Responsibilities and Duties:

In order of importance, describe 4 to 6 of the primary responsibilities and duties.  In Sections 3 and 4, describe how the position aligns to the job grouping criteria of Scope of Responsibilities and Impact on Business Results.

% of Time

(estimated)

Responsibilities:  Each responsibility is a grouping of tasks/duties.  Do not create a list of individual tasks.  Generally each position has 4 to 6 responsibilities.  See the Guidance Document for examples of responsibilities.

25%

Accountable for the operations of the PAS MA Laboratory, including but not limited to: people management, budgeting and resource allocation.

25%

Responsible for the Management of the PAS MA Product Lifecycle Engineering (PLE) team and will represent Medical Affairs at the Sustaining Engineering and Cost to Win governance teams ensuring a  patient –centric focus on portfolio decisions.

25%

Medical Governance: Accountable for clinical trial excellence for all BD PAS studies- safety and efficacy as well as post market studies. Responsible for providing medical expertise for timely completion of Situation Analysis, Health Hazard Evaluations and NCMRS.

10%

Participates in PAS Innovation activities by sensing and defining key trends in science, technology, medical practice, and health economics and interaction with PAS Innovation Teams.

10%

Responsible for the scientific integrity and clinical accuracy of all claims and communications made concerning PAS products. As part of the MA Leadership team, ensures high standards of compliance in all aspects of Medical Affairs activities as well as drives continuous improvement to increase efficiency and effectiveness of Medical Affairs through well defined processes.

May take on other responsibilities as required

Scope of Responsibility:

Strategic Orientation: Describe the degree to which the position has responsibility for influencing and/or developing strategies for achieving company goals. Provide an example(s):

As part of the PAS MA LT contributes to the development of the PAS MA strategy.

Ultimately responsible for execution of all internal clinical studies throughout the BD PAS product life cycle (new product development, sustaining engineering and post-market), data analysis and review.

Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning PAS products globally.

Sphere of Influence: Describe the degree to which a position influences and guides business activities, decisions and processes within a function or unit, as well as across organization boundaries.  Provide an example(s).

Member of the world wide PAS Medical Affairs leadership team and the Global Clinical Council Core Team.

Plays an important role in resource planning within PAS MA by managing MA resourcing for PLE projects and for all internal clinical trials conducted by PAS MA Laboratory Operations Team.

Does this position have direct reports? If so, approximately how many? Attach organizational chart:

Two direct reports: Clinical Laboratory Manager, and  Senior Manager, Medical Affairs PLE Team.

Example of teams(s) membership/leadership

PAS MA Leadership Team, GCC Core Team, SE and PLE Governance Teams

    Examples of internal (BD) contacts:

Core Team Leaders, PAS Innovation Teams, PAS Global Marketing, PAS Regional Medical Affairs, PAS MA Leadership team

Examples of external (outside of BD) contacts:

KOLs in Laboratory Medicine, relevant Professional Organizations

 Impact on Business Results

Degree of Accountability:  Describe the degree to which the position entails making key decisions that affect business performance and provide examples.

Accountable for clinical study design for all internal and external clinical studies throughout the BD PAS product life cycle (new product development, sustaining engineering and post-market), data analysis and review.  Accountable for scientific integrity and clinical accuracy of all claims and communications made concerning these products globally.  MA delegate for all PAS Blue Folder reviews and approvals.

Will be responsible to conduct all health risk assessments and NCMRS within PAS and recommend field actions in case of product issues.

If applicable, impact on quality; works with Quality and Regulatory Compliance to assess impact of product issues on patient’s health.

Financial Impact:  Describe the degree to which the position has an impact on those things that drive revenue    generation and profitability and provide examples.

The key financial impact of this position is on the timely delivery on new products to the market and the ability to meet planned growth targets.  Also, through the accountability of safety and efficacy of all BD PAS products, this role has the impact on execution of projected sales targets through assessment of potential product deficiencies and need to remove affected product from the market.

If applicable, what are the budget responsibilities?  Responsible for managing the budgets of all internal PAS clinical trials and for PAS MA Laboratory Operations.

If applicable, what is the impact on cost?

 Essential Functions

The purpose of this section is to help identify any modifications or adjustments to the work environment that might enable a qualified individual with a disability to perform the essential functions of the position.  If there are any additional functions (not identified in the responsibilities section above), including physical capacities, that require a significant amount of time, and that would lead to a serious consequence if not performed, identify and describe those essential functions here. Please refer to the Guidance document for more information.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

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Confirmed 16 hours ago. Posted 30+ days ago.

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