Clinical Development Scientist

Job TitleClinical Development Scientist

Job Description

You are responsible for

Developing and delivering evidence generation / dissemination strategies (EGS / EDS); including, but not limited to, study design, scientific validity, data integrity, strategic guidance and reporting, with guidance as indicated, from senior members of the Clinical & Scientific Affairs (C&SA) team.

This Clinical Development work to support the Sleep and Respiratory Care (SRC) Business Group (BG) and:

  • Will provide strategic input into clinical aspects related Scientist will to the end to end (E2E) BG portfolio, from ideation through post marketed products
  • Works closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as Key Opinion Leaders (KOL) and subject matter experts (SME's), etc.) stakeholders to ensure that studies will yield well-founded conclusions.
  • With minimal oversight, responsible for professional collaboration with, investigators, IRB's/EC's, Regulatory Agencies, societies, associations, etc.
  • Additional collaboration may occur to support claims, reimbursement, health economic outcomes and / or market access.
  • Through active cooperation with physicians, medical researchers and scientific writing personnel, the clinical development scientist will work to support the interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer reviewed manuscripts, etc.

Act as a 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

o Ensure that studies (clinical and non-clinical) are appropriately designed, and that the results are appropriately analyzed and accurately reported

  • Develop study protocols in compliance with project standards and specifications and regulatory guidelines (GCP, ICH, FDA, ISO) o Keep current with regulatory guidance and requirements in the global environment

Provide support for the strategy and design of clinical trials in the United States of America (USA), Europe (EU) and rest of world (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

o Contribute to process improvements, as appropriate

Ensure development, with appropriate inputs, for the following high level deliverables, with minimal oversight: o Regulatory and Clinical Risk assessment

o Literature Review and Evidence Scan

o Clinical Strategy

o Clinical Development Plan (Roadmap)

o Vendor Selection and Qualification

  • Provide input, as required, to the CRFs, data structure and monitoring plans
  • Author protocols, clinical study reports and contribute to publications
  • Identify and support the preparation and development of clinical trial documentation with minimal guidance

o Protocol, Investigator Brochure, Consent Form, and Case Report Form

  • Indirectly support approval applications, as required and monitor approvals

o EU - Ethics approval, Competent Authority applications

o US - IRB (Institutional Review Board), IDE (Investigational Device Exemption), 510(k) (PreMarket Notification), and PMA (Pre-Market Approval) and FDA Panel meeting.

You are a part of

A position that 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 only limited 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 in this role, 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
  • Clinical research knowledge and cross-functional understanding of clinical trial methodology and operational experience is a must
  • 5+ 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
  • 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

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on 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.

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.

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.



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