Clinical Development Scientist

5 days ago

Bothell, United States Randstad USA Full time

Job Title: Clinical Development Scientist

Contract, Hybrid work schedule in Bothell WA location.

$95-105/hr

Full time hours


Responsibilities:

  • Lead the development of evidence generation strategies for assigned projects, aligning with the value proposition to address the evidence needs of key stakeholders.
  • Deliver comprehensive Clinical Development Plans that outline strategies for clinical evaluation in accordance with internal and external requirements (e.g., US, EU, China).
  • Collaborate with internal stakeholders (e.g., project owners, regulatory teams, statisticians, clinical study managers, business leaders) and external partners (e.g., clinical consultants, key opinion leaders, subject matter experts) to ensure study outcomes are robust and well-supported.
  • Design and develop study protocols adhering to project standards, regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR), and oversee study execution, analysis, and reporting to support regulatory clearances, claims, and market access.
  • Partner with Clinical Operations to deliver assigned clinical programs effectively.
  • Develop and disseminate evidence generated from clinical evaluation plans, including Clinical Evaluation Reports, Clinical Study Reports, and manuscripts, ensuring alignment with global requirements.
  • Lead discussions related to clinical evidence and epidemiology/surveillance with regulators, advisory boards, and professional societies.
  • Stay updated on global regulatory guidance and requirements, ensuring compliance across clinical programs.
  • Interpret and disseminate evidence through reports, peer-reviewed publications, abstracts, and presentations.
  • Support medical safety initiatives, including signal detection and evaluation.
  • Drive the development of innovative data partnerships to advance data network strategies.
  • Create systematic processes for data infrastructure, such as data dictionaries, and evaluate real-world data vendors and access models.
  • Support the Data Governance Council in implementing de-identification and data use standards, including data tokenization.


Qualifications:

  • Advanced degree (MD, PhD, or MS in Biomedical Science, Epidemiology preferred).
  • A minimum of 7 years of experience in clinical research, development, or real-world evidence (RWE), with a preference for medical device expertise.
  • Strong scientific background and expertise in evidence generation, clinical evaluation, and RWE methodologies, including innovative trial design and data network development.
  • Proficiency in machine learning/artificial intelligence algorithm validation.
  • Deep knowledge of global clinical evidence requirements, including regulatory pathways, and standards such as GCP, FDA regulations, EU MDR, and ISO14155.
  • Knowledge of RWE applications for regulatory decision-making.
  • Ability to critically assess clinical literature and write original scientific documents, including clinical study reports, regulatory filings, and peer-reviewed publications.
  • Strong communication skills, including the ability to present scientific materials effectively.
  • Proven ability to lead cross-functional teams, influence without direct authority, and deliver clinical evidence strategies on time and within budget.

This role reports to the Director of Clinical Affairs and requires a collaborative, detail-oriented professional with a passion for clinical innovation and regulatory excellence.

  • Scientist

    4 weeks ago

    Bothell, United States Net2Source Inc. Full time

    Please find below the job description.Title: Bench Scientist Location: Bothell, WADuration: 18 MonthsPayrate: $45- $50/hr on w2 without benefitsPOSITION SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for...

  • Scientist

    4 weeks ago

    bothell, United States Net2Source Inc. Full time

    Please find below the job description.Title: Bench Scientist Location: Bothell, WADuration: 18 MonthsPayrate: $45- $50/hr on w2 without benefitsPOSITION SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for...

  • Scientist

    4 weeks ago

    bothell, United States Net2Source Inc. Full time

    Please find below the job description.Title: Bench Scientist Location: Bothell, WADuration: 18 MonthsPayrate: $45- $50/hr on w2 without benefitsPOSITION SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for...

  • Randstad USA | Clinical Development Scientist | bothell, wa

    4 days ago

    bothell, United States Randstad USA Full time

    Job Title: Clinical Development ScientistContract, Hybrid work schedule in Bothell WA location. $95-105/hrFull time hoursResponsibilities:Lead the development of evidence generation strategies for assigned projects, aligning with the value proposition to address the evidence needs of key stakeholders.Deliver comprehensive Clinical Development Plans that...

  • Bench Scientist

    2 weeks ago

    bothell, United States eTeam Full time

    Title: Bench ScientistLocation: Bothell, WADuration: 18 MonthsPay Rate: $50/hrPOSITION SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for recombinant proteins and biological macromolecules for early- and...

  • Bench Scientist

    2 weeks ago

    Bothell, United States eTeam Full time

    Title: Bench ScientistLocation: Bothell, WADuration: 18 MonthsPay Rate: $50/hrPOSITION SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for recombinant proteins and biological macromolecules for early- and...

  • Senior Associate Scientist

    4 weeks ago

    bothell, United States Randstad Life Sciences US Full time

    Title: Senior Associate Scientist- First ShiftDuration: 18 MonthsLocation: Bothell, WA 98021 Pay Rate: $49/hr on W2Shift: Monday-Friday 8:00am-4:00pm. - 100% ONSITE in CambridgeJob DescriptionThe Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and...

  • Senior Associate Scientist

    4 weeks ago

    Bothell, United States Randstad Life Sciences US Full time

    Title: Senior Associate Scientist- First ShiftDuration: 18 MonthsLocation: Bothell, WA 98021 Pay Rate: $49/hr on W2Shift: Monday-Friday 8:00am-4:00pm. - 100% ONSITE in CambridgeJob DescriptionThe Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and...

  • Clinical Data Management Lead

    4 weeks ago

    Bothell, Washington, United States Pfizer Full time

    Job DescriptionJob Title: Clinical Data Scientist ManagerJob Summary: We are seeking a highly skilled Clinical Data Scientist Manager to join our team at Pfizer. As a Clinical Data Scientist Manager, you will be responsible for leading the development and implementation of clinical data management strategies and plans to support the Pfizer portfolio.Key...

  • Bench Scientist

    3 weeks ago

    Bothell, WA, United States eTeam Full time

    Title: Bench ScientistLocation: Bothell, WADuration: 18 MonthsPay Rate: $50/hrPOSITION SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for recombinant proteins and biological macromolecules for early- and...

  • Clinical Affairs Consultant

    1 month ago

    bothell, United States Eliassen Group Full time

    Clinical Affairs Consultant (Hybrid 3 days on-site)You are responsible for:• 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 Affairs Consultant

    1 month ago

    bothell, United States Eliassen Group Full time

    Clinical Affairs Consultant (Hybrid 3 days on-site)You are responsible for:• 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 Affairs Consultant

    1 month ago

    Bothell, United States Eliassen Group Full time

    Clinical Affairs Consultant (Hybrid 3 days on-site)You are responsible for:• 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 Research Associate

    2 weeks ago

    bothell, United States eTeam Full time

    Job Title: Clinical Research Associate(QC Sample Handling Technician)Duration: 12 monthsLocation: Bothell, WAJob Summary• The Clinical Research Associate(QC Sample Handling Technician) will be part of a multi-discipline support staff with primary responsibility for receiving, aliquoting, distributing, handling and documentation of GMP samples in support of...

  • Clinical Research Associate

    3 weeks ago

    bothell, United States eTeam Full time

    Job Title: Clinical Research Associate(QC Sample Handling Technician)Duration: 12 monthsLocation: Bothell, WAJob Summary• The Clinical Research Associate(QC Sample Handling Technician) will be part of a multi-discipline support staff with primary responsibility for receiving, aliquoting, distributing, handling and documentation of GMP samples in support of...

  • Clinical Research Associate

    3 weeks ago

    Bothell, United States eTeam Full time

    Job Title: Clinical Research Associate(QC Sample Handling Technician)Duration: 12 monthsLocation: Bothell, WAJob Summary• The Clinical Research Associate(QC Sample Handling Technician) will be part of a multi-discipline support staff with primary responsibility for receiving, aliquoting, distributing, handling and documentation of GMP samples in support of...

  • QC Sample Handling Technician

    3 weeks ago

    bothell, United States eTeam Full time

    Job Title: Clinical Research AssociateDuration: 12 monthsLocation: Bothell, WAPay rate: $27/hr.Job Summary• The QC Sample Handling Technician will be part of a multi-discipline support staff with primary responsibility for receiving, aliquoting, distributing, handling and documentation of GMP samples in support of multi-product and multi-site testing...

  • QC Sample Handling Technician

    3 weeks ago

    Bothell, United States eTeam Full time

    Job Title: Clinical Research AssociateDuration: 12 monthsLocation: Bothell, WAPay rate: $27/hr.Job Summary• The QC Sample Handling Technician will be part of a multi-discipline support staff with primary responsibility for receiving, aliquoting, distributing, handling and documentation of GMP samples in support of multi-product and multi-site testing...

  • Bioprocess Specialist

    4 weeks ago

    Bothell, Washington, United States Net2Source Inc. Full time

    Job Title: Senior Associate ScientistJob Summary: We are seeking a highly skilled Senior Associate Scientist to join our Bioprocess R&D team at Net2Source Inc. This is a unique opportunity to work on the development and optimization of recovery and purification processes for recombinant proteins and biological macromolecules.Key Responsibilities:Design and...

  • Research Associate III

    2 months ago

    Bothell, United States Actalent Full time

    Job DescriptionJob DescriptionJob Title: Research Associate IIJob DescriptionThe Downstream Process Development group in Bioprocess R&D is seeking an Associate Scientist contractor to support development and optimization of recovery and purification processes for recombinant proteins and biological macromolecules for early- and late-phase clinical trials....