Integrated Resources, Inc

1 week ago

cambridge, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: Clinical Development Scientist

Job Type: 6+Months with possible extension

Location: Bothell, WA or Cambridge, MA


Responsibilities:

• Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholders

• Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements (US,EU, China, etc)

• Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions.

• Design and development of study protocols in compliance with project standards, specifications and applicable regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR). Manage and oversee study execution, analysis of results and generation of final study reports to support client regulatory clearances, claims, reimbursement, health economic outcomes and/or market access.

• Deliver assigned clinical programs, working in partnership with Clinical Operations.

• Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports and Clinical Summaries, and manuscripts

• Lead clinical evidence discussions with regulators (deficiency requests/FDA, Notified Bodies, etc), advisory boards, associations, and societies

• Keeping current with regulatory guidance and requirements in the global environment.

• Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc.


You are a part of Clinical Affairs:

The Clinical Development Scientist reports to the Director of Clinical Affairs in the business.


To succeed in this role, you should have the following skills and experience:

• An MD, PhD/MS Degree in Biomedical science strongly preferred.

• 7+ years’ experience in clinical research/development function; (medical devices preferred)

• Strong scientific background and deep expertise in the development of clinical evaluation and research methodologies, including innovative clinical trial design and working knowledge of biostatistics.

• Deep understanding of global clinical evidence requirements, including regulatory paths, and deep knowledge and understanding of all applicable standards/regulations in clinical evidence generation and dissemination, including Good Clinical Practice (GCP), FDA requirements, EU MDR (ISO14155, CFR Part 812, Med Dev 2.7.1 (rev4))

• Strong ability to critically assess clinical literature

• Excellent communication skills, including written communication (e.g., peer- review publication) and oral presentation of scientific materials and research results. Ability to write original scientific documents such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.

• Ability to work collaboratively with cross-functional partners, shape, and lead without direct reporting authority, highly enthusiastic, self-motivated individual who will accept accountability

• Proven track record in successfully developing and executing clinical evidence strategies for regulatory submissions, on-time within budget and in compliance with SOPs and regulations.

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