Senior Clinical Development Scientist

Philips • San Diego, CA

19d • Onsite

About The Position

Senior Clinical Development Scientist, IGTD Coronary In this role, you have the opportunity to work with a cutting edge product line - IGT Devices is part of the Philips Image Guided Therapy (IGT) business group. As the Senior Clinical Development Scientist, you will be responsible for developing and delivering evidence generation/dissemination strategies for multiple and/or complex projects; including, but not limited to, study design, scientific validity, data integrity, strategic guidance and reporting. Your role: Provide strategic input for all clinical aspects of the end-to-end coronary clinical development portfolio—from initial concept through post-market products—including study design, product development, and validation testing. Collaborate closely with both internal teams (such as project owners, regulatory, clinical study managers, statisticians, and business leaders) and external stakeholders (including clinical consultants, Key Opinion Leaders, and subject matter experts) to ensure clinical safety and performance objectives are met. Work professionally with investigators, animal test laboratories, regulatory authorities, societies, and associations to support research initiatives and regulatory compliance. Support claims, reimbursement, health economic outcomes, and market access strategies in partnership with internal teams, and take an active or leading role in the publication and dissemination of study results through scientific writing and collaboration with physicians and medical researchers. Lead or support scientific discussions with regulatory agencies and notified bodies to advance clinical and regulatory strategies, including facilitating clinical investigations, reviewing clinical evidence for marketing authorization and line extensions, and supporting sponsor regulatory inspections.

Requirements

• 10+ years of experience in a similar role in the medical device industry; and experience in representing the clinical function in cross-functional product development teams.
• Strong writing experience to product quality clinical documents, including final reports.
• demonstrated working knowledge of GCP, ICH guidelines, FDA regulations (21 CFR 812) and EU (ISO 14155) regulations
• deep understanding of product development and associated design controls within the operational framework of a Quality Management System for medical devices
• extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and operational experience is a must.
• Strong data analysis capabilities and experience with relevant software strongly preferred (SAS/SPSS is a plus).
• You have a master’s degree or higher in Biomedical Science, Engineering, or Health related field, with extensive experience in doing research for industry.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator (written and verbal) with a proven ability to collaborate effectively with a variety of teams and stakeholders
• self-directed with a strong work ethic, with an ability to work in a goal-oriented environment.
• You have strong analytical thinking skills, ability to present statistical methods and results to a variety of audiences.

Nice To Haves

• Strong data analysis capabilities and experience with relevant software strongly preferred (SAS/SPSS is a plus).

Responsibilities

• developing and delivering evidence generation/dissemination strategies for multiple and/or complex projects; including, but not limited to, study design, scientific validity, data integrity, strategic guidance and reporting.
• Provide strategic input for all clinical aspects of the end-to-end coronary clinical development portfolio—from initial concept through post-market products—including study design, product development, and validation testing.
• Collaborate closely with both internal teams (such as project owners, regulatory, clinical study managers, statisticians, and business leaders) and external stakeholders (including clinical consultants, Key Opinion Leaders, and subject matter experts) to ensure clinical safety and performance objectives are met.
• Work professionally with investigators, animal test laboratories, regulatory authorities, societies, and associations to support research initiatives and regulatory compliance.
• Support claims, reimbursement, health economic outcomes, and market access strategies in partnership with internal teams, and take an active or leading role in the publication and dissemination of study results through scientific writing and collaboration with physicians and medical researchers.
• Lead or support scientific discussions with regulatory agencies and notified bodies to advance clinical and regulatory strategies, including facilitating clinical investigations, reviewing clinical evidence for marketing authorization and line extensions, and supporting sponsor regulatory inspections.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior