Philips Sr. Manager, Clinical Affairs in San Diego, California
As the Senior Manager of Clinical Affairs, you will have the operational management responsibility of clinical trials for cardiovascular and peripheral vascular medical devices.
This exciting position is responsible for managing the development of the clinical investigational plans including the protocol, operational plans, data management, statistical and monitoring plans, developing and managing site relationships, trial conduct through enrollment and reporting using internal and external resources.
You will also work in collaboration with Investigators, Marketing, Regulatory, and R&D to assure clinical trials result in successful regulatory filings, marketing claims, and other customer and US and international business needs.
Work in conjunction with Clinical Science to develop clinical trial strategies and protocols by collaborating with Investigators, Regulatory, Marketing, and R&D to develop clinical trial strategies, plans and protocols.
Development includes knowledge of relevant medical literature, regulatory environment, marketing requirements and the performance characteristics of the devices.
Partnership with resources for statistical and data management plans is required, as well.
Oversee and manage a clinical team to assure clinical trials are executed successfully - this includes site development and management, subject recruitment, maintenance of data integrity and regulatory compliance, project timeliness, budget oversight and all aspects of study communications.
Develop study materials to support trial conduct such as case report forms, investigator brochures, and core lab documents.
Develop and manage performance metrics (trial and personnel) for internal and external resource assessments.
Develop and manage relationships with key medical and scientific investigators, CECs, DSMBs, CROs and Core Laboratories - activities would include contract negotiations, developing vendor milestones and metrics for efficient trial conduct.
Develop and manage trial budgets to key business objectives.
Lead, maintain and anticipate regulatory compliance objectives and documentations requirements in US and international trial executions.
Ensure that safety requirements are met through adverse event reporting which may also include support of medical monitoring, CEC review and DSMB review as individual trials require.
Facilitate and participate in clinical trial reports on all aspects of a study for regulatory submissions, marketing support and other business needs.
Support regulatory and quality assurance requirements throughout the product life cycle - this may include special reports for regulatory body requests, complaints, product investigations, marketing needs or other customers.
Develop, manage and oversee the staff and communication requirements (internal and external) to meet clinical trial needs in an effective and efficient manner.
What you will bring
Demonstrated in-depth knowledge of medical device development, clinical trial management of Class II and III devices, and understands the application of appropriate FDA, GCP, and ISO Standards to meet regulatory and compliance requirements.
Demonstrated ability to supervise, lead and develop technical staff members.
Ability to build and maintain partnerships with internal customers and stakeholders.
Demonstrated ability to plan, implement and manage multiple projects in a fast-paced environment. Ability to manage projects with direct and indirect resources required.
Demonstrated ability to develop, influence and manage relationships with medical and scientific investigators, CECs, DSMBs, CROs and Core Laboratories. Including contract negotiations, developing vendor milestones and metrics to achieve business objectives.
Strong medical and scientific writing skills with ability to author protocols, literature reviews and technical study documents.
Strong analytic skills for strategic review and assessment of the medical literature, clinical and statistical data interpretation and scientific study proposals and oversee data management activities.
BS in Life Sciences, advanced or professional degree preferred.
Minimum of 10 years’ experience in medical device industry.
Track record of clinical trials management and execution for medical devices.
In-depth knowledge of regulatory compliance requirements for FDA and CE Mark
Work in Japan would be considered a plus
- In-depth experience in cardiovascular and peripheral vascular devices desired .
- Travel up to 40% of the time, may include international, as well.
Location: San Diego, CA
Reports to: Senior Director: Global Clinical Affairs Peripheral Vascular, Clinical - U.S.
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Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.