As the Director, Clinical Development for Philips Volcano, you will lead the development and deliver evidence generation and dissemination strategies to support full product life cycle management for the peripheral product portfolio.
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 related to the product lifecycle management.
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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.
Serve as group leader with product development and marketing leaders to set priorities.
Provide input on strategic decisions and ensure clinical affairs representation in core team meetings and activities.
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.
Drives setting of team goals and milestones; monitors progress.
Represents the study team and/or department during meetings with senior management, FDA, and other global regulatory authorities, business or functional groups.
Minimum Qualifications, Knowledge, Skills and Abilities:
Education:
Requires a minimum of a bachelor's degree in a scientific discipline, advanced or professional degree desirable.
Knowledge and Experience:
Requires 10+ years directly related experience in clinical/scientific experience including leadership or management role within device industry.
Requires 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.
Comprehensive understanding of applicable clinical research regulations in multiple regions.
Requires 5+ years' experience in conducting preclinical studies with development-stage medical devices
Experience interacting with top-level executives
Knowledge and experience with FDA device regulations, writing FDA reports, medical device clinical trial practices, GCPs and elements of Informed Consent. In-depth knowledge of medical device development regulatory requirements needed.
Skills and Abilities:
Demonstrated ability to build collaborative relationships with key internal and external stakeholders.
Ability to lead and influence through direct and indirect resources to shape organization.
Meticulous attention to detail and accuracy required
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships.
Demonstrated ability to manage multiple studies, staff and company initiatives effectively.
Ability to represent the Company at professional and business functions in a competent manner
Develops and implements effective solutions to a variety of problems; ensures solutions are consistent with organizational objectives
Desirable Qualifications:
Experience with medical devices used in a catheterization lab
Practical experience with clinical research studies, in the cardiovascular, peripheral vascular or electrophysiology medical device applications in a sponsor company, or equivalent.
Lead and shape change in team settings.
Supervisory responsibility:
Will supervise exempt and nonexempt employees, with a variety of scientific backgrounds
Participates in hiring, goal-setting, performance evaluations, termination, promotion and merit decisions.
Travel requirements:
Travel 20-30% of the time to various customer and sponsor company locations, both domestically and internationally required
Location: San Diego, California
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