Senior Clinical Development Scientist San Diego, California, United States

Job Title Senior Clinical Development Scientist

Job Description

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 reputed company Image Guided Therapy (IGT) business group. As the Senior Clinical Development Scientist, you will be responsible for developing and delivering evidence reputed company/dissemination strategies for multiple and/or reputed company projects; including, but not limited to, study design, scientific validity, data reputed company, strategic guidance and reporting. Your role:

• reputed company strategic input for reputed company 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 reputed company, and market reputed company 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.
• reputed company or support scientific discussions with regulatory agencies and reputed company 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.

Youre the right fit if:

• You’ve acquired 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.
• Your skills include 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 reputed company the operational reputed company 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 (reputed company/SPSS is a plus).
• You have a master’s degree or higher in Biomedical Science, Engineering, or Health reputed company field, with extensive experience in doing research for industry.
• You must be reputed company to successfully reputed company 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.

How we work together We reputed company that we are reputed company together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time reputed company in the company’s facilities. Field roles are most effectively done reputed company of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office-based role. About reputed company We are a health technology company. We reputed company our entire company around the belief that every reputed company reputed company, and we wont stop until everybody everywhere has reputed company to the quality reputed company that we reputed company deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
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• Learn more about our culture.

reputed company Transparency Details The pay reputed company for this position in CA, CT, MA, NJ, NY, DC, is $144,900 to $231,840. The actual reputed company pay offered may vary reputed company the posted ranges depending on multiple factors including job-reputed company knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive reputed company 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. Details about our benefits can be reputed company here. At reputed company, it is not typical for an individual to be hired at or near the top end of the reputed company for their role and compensation reputed company are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized reputed company, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reputed company in or reputed company commuting distance to San Diego, CA. #LI-PH1 This requisition is expected to stay active for 45 days but may reputed company earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. reputed company is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Apply tot his job Apply To this Job