Associate Director Clinical Affairs
- Carlsbad, CA
Associate Director Clinical Affairs
In this role, you will be responsible to develop and deliver evidence generation / dissemination strategies (EGS / EDS) for multiple and / or complex projects; including, but not limited to, study design, scientific validity, data integrity, strategic guidance and reporting.
You are responsible for
- Act as lead consultant to build effective partnerships and working relationships within SRC, and at times broader across different businesses within Philips
- Design clinical studies that result in scientifically sound and valid data
- Ensure that studies (clinical and non-clinical) are appropriately designed, and that the results are appropriately analyzed and accurately reported
- D evelop study protocols in compliance with project standards and specifications and regulatory guidelines (GCP, ICH, FDA, ISO)
- Keep current with regulatory guidance and requirements in the global environment
- Contribute to applications for registration purposes by providing leadership in standardizing and optimizing strategic clinical study input
Essential Job Functions:
- Provides support for the strategy and design of clinical trials in the USA, EU and ROW.
- Maintain efficient interfaces and relationships with regulatory, product development, marketing and clinical operational teams
- Work according to Good Clinical Practice (GCP), rules and regulations and internal procedures
- Contribute to process improvements, as appropriate
- Ensure development, with appropriate inputs, for the following high level deliverables:
- Regulatory and Clinical Risk assessment
- Literature Review and Evidence Scan
- Clinical Strategy
- Clinical Development Plan (Roadmap)
- Vendor Selection and Qualification
- Provide input, as required, to the CRFs, data structure and monitoring plans
- Author protocol, clinical study reports and contribute to publications
- Identifies and supports the preparation and development of clinical trial documentation
- Protocol, Investigator Brochure, Consent Form, and Case Report Form
- Directly or indirectly support approval applications, as required and monitor approvals
- EU - Ethics approval, Competent Authority applications
- US - IRB (Institutional Review Board), IDE (Investigational Device Exemption), 510(k) (Pre- Market Notification), and PMA (Pre-Market Approval) and FDA Panel meeting.
You are part of In this role you will be working within the Sleep and Respiratory Care (SRC) Business Group and offers the opportunity to impact lives through the development and testing of quality Philips products and solutions that help countless people all over the world. We have a fantastic work environment and culture that is respectful and rewarding, that offers opportunities to develop and grow both personally and professionally. These opportunities are limited only by one's initiative and desire to succeed. The ability of this position to work with both internal and external customers promotes a broader vision to additional opportunities across Philips as a global company.
To succeed, you should have the following skills and experience
- Scientific education (preferably Masters or PhD degree preferred in BioMedical Science or Health related field), with extensive experience in doing research for industry
- A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations (21CFR812) and EU (ISO14155) regulations
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and operational experience is a must
- >10 years of experience in a similar role in the Medical Device or Pharma industry
- Excellent verbal and written communication skills (English); multiple languages is a plus
- Ability to collaborate effectively with various teams - clinical operations, engineering, cross-functional team members, as well as external partners
- Self-directed with a strong work ethic, with an ability to work in a goal-oriented environment
- Strong writing skills to produce quality clinical documents, including final reports
- Analytical thinking, able to present statistical methods and results to a variety of audiences, especially non-statisticians
- Proactive and flexible attitude with strong work ethic
- Able to quickly assess and understand stakeholder needs
- Ability to set priorities, work independently without direct supervision as well as part of a team
- Conscientious and precise delivery of work, even when under time pressure
- Open and clear communicator
- Proven track record of delivering clinical results, on time, within budget and in compliance to SOPs and regulations;
- Comprehensive understanding of clinical trial regulations across multiple regions and work precisely according to procedures, rules and regulations and able to keep oversight on processes
- Ability to lead teams to deliver critical milestones
- Results-oriented, Quality driven
- Able to travel, including international (25% travel, or more at times)
- Proficient computer skills across multiple applications (MS Office, with experience in and an aptitude for clinical trial software, proven ability to apply statistics into method development and sample analysis, experience with SAS / SPSS statistical software is a plus
We offer you Enjoy endless opportunities to learn, and develop your career in the directions to which you seek. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to build your own legacy.
Why should you join Philips?
This is more than a job. It's a calling to create a healthier society through meaningful work, passionate about improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That's okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA .
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