Director, Clinical Safety

Position : Director, Clinical Safety, Req# : 8819-1

Location : Irvine, CA ( Remote)

Duration : 6+ Months Contract (Part-Time job, 20 hours per week)

More on this position :

What does your group do? We are responsible for generating, disseminating, and educating on the evidence for our innovation portfolio

Does your team use any specific technology / software you want us to look out for? Yes, standard industry tools and systems

What will a typical workday look like? Every day is different

What will the work schedule be? Can any overtime be expected? 20 hours per week for the year but varies week to week

Each day varies so its generally ad hoc and event-dependent. Certain meetings are pre-established (once per month etc)

Will there be any travel involved? Yes

Travel will depend on many factors : eg if internal, most will be Irvine...if external (eg conferences) will be where the conference is.

Will you consider remote work? If yes, will they need to be in a specific time zone? Yes

What are your top 3 required technical skills? Must haves? Preferred technical skills : Clinical skills as a CT surgeon, understanding of the ST surgery industry and space, understanding of the rules and stakeholders (government and customers)

Job Description :

Provide strategic, technical, and risk / benefit decisions on behalf of MACA and partnering with Marketing, Commercial, Quality, R&D, Regulatory Affairs and others as a physician expert and ambassador for projects needing qualified medical input and activities.

Education and Experience :

Doctor of Medicine in M.D. and board certification in Cardiothoracic Surgery or equivalent medical training, 10 years of previous clinical practice experience.

Experience in rules on Class II and III medical device technologies

Additional Skills :

Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with the ability to drive the achievement of objectives

Recognized as an expert within MACA, supporting commercial, R&D, and Regulatory Affairs and broader organization with broad-based expertise across area and related functions

Expert understanding of clinical studies procedures while identifying applications of functional knowledge and existing methodologies to complex problems

Expert understanding of related aspects of processes and / or systems

Strict attention to detail

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Ability to interact with other medical professionals to help understand product issues and identify potential solutions with appropriate internal Edwards teams

Have established relationships in the clinical areas of focus for Heart Valve Therapies.

Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment

Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence / control

Key Responsibilities :

Serve as an expert medical liaison between the SURG business and customers regarding our portfolio, their use in practice, and benefits as a physician expert to drive market development and adoption through evidence and education, support Client opportunity assessments, practice trends, advocacy and relevant strategic insights

Participate in medical risk / benefit evaluations and technical troubleshooting for Clinical Evidence Reports, safety evaluations, risk management and PMS reviews, and corrections / removals, as required.

Provide technical expertise to product development, professional education, design validation, RA, and Quality / RM including literature review and evaluation of evidence

Collaborate with new product development, professional education, MKT, and other functional activities providing his / her surgical insights to support innovation, go-to-market strategies, evidence and claims, to challenge the status quo

Help raise the organization's clinical acumen by providing expert guidance to Clinical Affairs, Regulatory Affairs, R&D, new product development, pre-clinical support and other teams to expand knowledge of patient disease treatments and physician expectations for product use.

Act as subject matter expert (or as a chairperson) in external and internal meetings and symposia by engaging stakeholders and teams where either general medical expertise is required or where specific (specialty training) medical input is required.

Other incidental duties

TB HL