Medical Director & Medical Safety Officer

Agilent Technologies•Carpinteria, CA

4d•Remote

About The Position

Life Sciences and Diagnostics Group (LDG)’s Medical Director & Medical Safety Officer will have a major impact on the organization and company’s transformation, will have accountability for the safety program and will support the global Medical Affairs team. Reporting to the VP, CMO , the Medical Director & Medical Safety Officer will help build and cultivate Agilent's presence in healthcare and scientific communities, enhancing relationships with key thought leaders and external collaborators.

Requirements

MD or MD/PhD is a must
8+ years relevant experience for entry to this level

Nice To Haves

Anatomic Pathology Board certification preferred
Industry experience preferred

Responsibilities

Serve as a Medical lead in collaboration with RA/QA and other SMEs to ensure Agilent products meet the highest standard of patient safety, i.e. timely assessment of customer complaints, any patient safety concerns
Serve as the escalated level of customer support for medically related product questions and will be the voice of the patient, serving as patient advocate in the company
Serve as a Medical lead in Adverse Events and Vigilance programs
In cooperation with the Sales & Marketing organizations, ensure that LDG's products are used in a safe, effective and ethical manner, consistent with the intent of the product labeling and regulatory and compliance requirements
Provide all necessary medical and scientific expertise and advice, as required, to internal Agilent departments, customers, key opinion leaders and other relevant external stakeholders like EQA programs
Ensure that all promotional and marketing materials meet Agilent standards of scientific and technical accuracy and integrity
Collaborates cross functionally to develop clinically meaningful educational content and protocols that reflect real world pathology and diagnostic practice
As the medical voice to the external community, represent Agilent at national, regional and international medical and scientific conferences and events, interacting with and influencing key opinion leaders and customers
Partner with RA/QA in the preparation of regulatory submissions and serve as the Agilent medical expert with global regulatory authorities, handling responses to regulatory agencies regarding questions about complex safety or efficacy issues
Develop, maintain and monitor processes/policies and ensure compliance with global regulatory requirements for global medical activities undertaken for launches and approved products
Help craft LDG’s strategy in the biomedical field and the push into new areas of science and precision medicine that are central to the future of medicine and the LDG strategy
Serve as a Medical Representative supporting Digital Pathology portfolio development.
Serve as an SME across the organization and support CDx and commercial efforts in Digital Pathology, including in global markets.
Help to evaluate emerging technologies and the competitive landscape
Functions as a medical advisor for Product Lifecycle, Marketing and R&D teams
Advise the Sales & Marketing organizations in maximizing the opportunity for customer acceptance and market penetration of LDG products