BD (Becton, Dickinson and Company) Medical Affairs- Medical Director, Clinical Operations in Franklin Lakes, New Jersey
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 is member of the World-Wide PAS MA Leadership Team and the 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 responsible for clinical study execution for Clinical studies supporting all aspects of FDA requirements 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. This position is also responsible for executing the clinical study portfolio to support FDA regulations by working closely with regulatory. Directly reporting to this position is the Clinical Laboratory Manager, MA Manager - FDA Projects.
Responsible for the operations of the PAS MA Laboratory Operations group, including but not limited to: people management, budgeting, and resource allocation.
Responsible for review of clinical study synopsis and protocols. Managing clinical studies conducted in PAS MA Clinical Laboratory and outside locations for PAS.
Work closely with PAS MA Leadership Team in preparation of response to FDA and ensure that all agreed timelines and deliverables are met.
Responsible for providing medical expertise for timely completion of Situation Analysis, Health Hazard Evaluations and NCMRS
Being a part of PAS MA Leadership Team may perform other duties as required
Strategic Orientatio n:
Responsible for supporting FDA related priorities such as clinical studies and risk assessment.
As part of the PAS MA LT contributes to the development of the PAS MA strategy
Responsible for the operations of the PAS MA Laboratory and timely completion of Situation Analysis, Health Hazard Evaluations and NCMRS.
Sphere of Influence :
Plays an important role in influencing key business decisions within PAS MA. Serves on 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 resourcing of internal clinical trials PAS MA Laboratory Operations
Clinical Laboratory Manager, MA Manager- FDA Projects.
PAS MA Leadership Team, GCC Core Team
Core Team Leaders, PAS Regional MA leaders, Regulatory and Quality.
KOLs in Laboratory Medicine.
Responsible for reviewing clinical study design for clinical studies throughout the BD PAS product life cycle (new product development, sustaining engineering and post-market), data analysis and review.
Responsible for the safety and efficacy of all products and services offered by PAS. Will be responsible to conduct all health risk assessments 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.
The key financial impact of this position is on the timely delivery on new products on the market and 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.
Responsible for managing the budgets of internal PAS clinical trials and for PAS MA Laboratory Operations.
KSA Requirements (Knowledge, Skills, and Abilities)
University degree in medicine (MD) and specialty training in clinical pathology.
Certifications a plus
License to practice medicine is a plus.
Experience in the field of laboratory medicine/pathology is required
Experience in a medical device/IVD company is a plus.
Strong knowledge of Laboratory Medicine
Knowledge of a scientific discipline related to Clinical Pathology
Strong knowledge of clinical laboratory operations
Knowledge of the preanalytical phase of the total testing process is a plus
Excellent interpersonal skills.
Demonstrated leadership skills.
Demonstrated strong customer/client orientation
Demonstrated capability for strategic thinking, excellent analytical and problem solving skills.
Ability to work with teams and to provide leadership within the medical community
Ability to integrate medical, scientific, and technical information and effectively communicate these data to the scientific community, customers, as well as throughout the organization.
Ability to network/develop relationships with KOLs
Project management skills
Strong competency in the areas of clinical study design, statistics, technical writing.
Demonstrated ability to understand, interpret and explain complex clinical and scientific information.
Strong communication skills (verbal, presentation, written).
Primary Work LocationUSA NJ - Franklin Lakes
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