Clinical Affairs Director, Cardiac Solutions

Job Title

Clinical Affairs Director, Cardiac Solutions

Job Description

Director, Clinical Affairs (Plymouth, San Diego, or Colorado Springs office-based)

As the Director of Clinical Affairs for Cardiac Solutions (Lead Extraction and Intracardiac Echocardiography) for Image Guided Therapy Devices for Philips, you will lead the development and deliver evidence generation and dissemination strategies.

You and your team will interact with Marketing, Regulatory, Quality, other functions, along with clinical and scientific leaders, to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, manuscript preparations, clinical evaluations and other deliverables.

Your role:

• Provide clinical research strategies, evidence development plans and protocol development with cross-functional teams including Marketing, Health Economics, Regulatory and R&D. Provide data for dissemination to meet the needs for market registrations, clinical and product marketing and further device development. 
• Lead a high-performing team to successfully drive these studies in accordance with appropriate quality standards including ICH/GCP, ISO and applicable FDA/global regulations along with company compliance requirements. Drives setting of team goals and milestones; monitors progress.
• Lead clinical scientific discussions with regulatory agencies, investigators and clinical thought leaders.  Interact with Marketing, Regulatory, Quality, and other functions to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, clinical evaluations and other deliverables related to the product lifecycle management.
• Leads and directs pre-market clinical affairs activities to ensure completion of all cross functional activities for product development activities.  This includes pre-clinical studies, risk management implementation, new product development processes and design history file development as clinical affairs team members. 
• Oversees design and implementation of preclinical studies for product development stage medical devices. Provide input on strategic decisions and ensure clinical affairs representation in core team meetings and activities. 
• Serve as group leader with product development and marketing leaders to set priorities. Represents the study team and/or department during meetings with senior management, FDA, and other global regulatory authorities, business or functional groups. 

You're the right fit if:

• You’ve acquired 10+ years of experience in clinical/scientific functional areas including leadership or management role(s) with the medical device industry. 5+ years’ experience in managing a clinical research functional team with proven track record in delivering complex clinical programs on time, within budget, and in compliance. You have 5+ years of experience conducting preclinical studies with development-stage medical devices. Experience with medical devices used in a catheterization lab preferred. Practical experience with clinical research studies, in the cardiovascular, peripheral vascular or electrophysiology medical device applications in a sponsor company, or equivalent.
• MD/PhD or equivalent is preferred, bachelor's or higher in a scientific discipline required.
• Your skills include a comprehensive understanding of applicable clinical research regulations in multiple regions, experience interacting with top-level executives, and strong knowledge and experience with FDA device regulations, writing FDA reports, medical device clinical trial practices, GCPs and elements of Informed Consent. You have in-depth knowledge of medical device development regulatory requirements as well.
• You’re able to travel occasionally as needed (20-30%) both domestic and internationally, and capable of working in an office/home office, as well as hospital/healthcare environment, adhering to requirements.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 

How we work together

We believe that we are better together than apart. For our office-based