W. L. Gore & Associates
Clinical Strategy Development Associate - Remote
W. L. Gore & Associates, Flagstaff, Arizona, United States, 86004
About the Role:
We are looking for a Global Clinical Research Strategist to join our team. In this role, you will develop product's global clinical research strategy that aligns to desired business outcomes. Primary accountability is development of the overall clinical research strategy that is translated into clinical study design(s), and then ensuring clinical study conduct and data output is in alignment with the study design and the overall clinical strategy.This is a remote position, and you can work from home in most locations within the United States.Responsibilities:Develop and document the global clinical research strategy for a product and/or disease state throughout the product lifecycle, including development of strategic data collections and clinical study designsIdentify and understand internal clinical data generation needs to inform global clinical research strategy and study design(s) through proactive collaborations with internal global, cross-functional stakeholders (Clinical Affairs, Regulatory, Health Economics, Marketing, Office of Medical Affairs, Business/Product Specialist)Drive alignment with internal global, cross-functional stakeholders (Clinical Affairs, Regulatory, Health Economics, Marketing, Office of Medical Affairs, Business/Product Specialist) on the global clinical research strategy, including alignment on the clinical research program and study design(s)Serve as a subject matter expert on clinical research strategy and clinical study design, strategically applying that expertise to effectively inform and meet business objectives and outcomesDevelop, review, and present content to US and OUS regulatory agencies (via clinical pre-submission consultations, IDEs, PMAs, annual reports, study progress reports, 510k submissions, Clinical Evaluation Plans, Clinical Evaluation Reports, Post-market clinical follow-up plans, EU design dossiers, etc.), and to external consultants and Key Opinion Leaders (KOLs) regarding clinical study design, study data, and overall clinical research strategyDevelop and document clinical study design rationalesProvide strategic input and review of clinical study documents and processes to ensure scientific integrity of study design and clinical strategy objectives are achieved in the planning, execution, and reporting of a clinical study. This includes but is not limited to input and review of the following: clinical study protocol, clinical study data and reports, statistical analysis plan, case report form specifications, tables/listings/figures, risk assessment documentation, site and investigator selectionDevelop and maintain in-depth clinical knowledge in disease and treatment space, on current and future directions of external clinical research environment and trial design, on US and OUS guidance/regulations, competitor research activities, etc. and update clinical research strategy and study design(s) as appropriateMaintain compliance with training expectations as required for this position
Required Qualifications:Bachelor's degree in engineering, life sciences, or related medical/scientific discipline with a minimum of 5 years of clinical research experience, including clinical study design and clinical research strategy development in medical device, pharmaceutical, biotech, or similar clinical applicationsExperience working with and effectively influencing cross-functional partners (i.e., Marketing, Health Economics, Regulatory Affairs, Clinical Affairs, Business)Experience working with clinician KOLs, regulatory agencies, and external consultantsFundamental knowledge of global clinical and regulatory requirements related to clinical study design and executionDemonstrated project planning and leadership, critical thinking, and problem-solving skillsStrong verbal and written communication skills in scientific and/or clinical disciplinesDemonstrated ability to develop deep understanding of clinical pathologies and clinical dataDemonstrated ability to critically research, synthesize, analyze, and appraise a breadth of scientific and medical literatureDemonstrated ability to work independently and in a group in a manner that is collaborative and productiveAbility to travel up to 15%
Desired Qualifications:Master's degree, PhD, or equivalent advanced degreeBasic understanding of biostatistics
This position requires access to export-controlled areas and information. Candidates must be "U.S. persons" as that term is defined in 8 USC *1324b(a)(3). The term "U.S. persons" includes resident aliens ("green-card" holders) as well as certain refugees, asylum-holders and residents qualifying for temporary residence under the terms of 8 USC *1255a.Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).What We Offer:
Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefitsWe believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact#LI-Hybrid#LI-REMOTE
We are looking for a Global Clinical Research Strategist to join our team. In this role, you will develop product's global clinical research strategy that aligns to desired business outcomes. Primary accountability is development of the overall clinical research strategy that is translated into clinical study design(s), and then ensuring clinical study conduct and data output is in alignment with the study design and the overall clinical strategy.This is a remote position, and you can work from home in most locations within the United States.Responsibilities:Develop and document the global clinical research strategy for a product and/or disease state throughout the product lifecycle, including development of strategic data collections and clinical study designsIdentify and understand internal clinical data generation needs to inform global clinical research strategy and study design(s) through proactive collaborations with internal global, cross-functional stakeholders (Clinical Affairs, Regulatory, Health Economics, Marketing, Office of Medical Affairs, Business/Product Specialist)Drive alignment with internal global, cross-functional stakeholders (Clinical Affairs, Regulatory, Health Economics, Marketing, Office of Medical Affairs, Business/Product Specialist) on the global clinical research strategy, including alignment on the clinical research program and study design(s)Serve as a subject matter expert on clinical research strategy and clinical study design, strategically applying that expertise to effectively inform and meet business objectives and outcomesDevelop, review, and present content to US and OUS regulatory agencies (via clinical pre-submission consultations, IDEs, PMAs, annual reports, study progress reports, 510k submissions, Clinical Evaluation Plans, Clinical Evaluation Reports, Post-market clinical follow-up plans, EU design dossiers, etc.), and to external consultants and Key Opinion Leaders (KOLs) regarding clinical study design, study data, and overall clinical research strategyDevelop and document clinical study design rationalesProvide strategic input and review of clinical study documents and processes to ensure scientific integrity of study design and clinical strategy objectives are achieved in the planning, execution, and reporting of a clinical study. This includes but is not limited to input and review of the following: clinical study protocol, clinical study data and reports, statistical analysis plan, case report form specifications, tables/listings/figures, risk assessment documentation, site and investigator selectionDevelop and maintain in-depth clinical knowledge in disease and treatment space, on current and future directions of external clinical research environment and trial design, on US and OUS guidance/regulations, competitor research activities, etc. and update clinical research strategy and study design(s) as appropriateMaintain compliance with training expectations as required for this position
Required Qualifications:Bachelor's degree in engineering, life sciences, or related medical/scientific discipline with a minimum of 5 years of clinical research experience, including clinical study design and clinical research strategy development in medical device, pharmaceutical, biotech, or similar clinical applicationsExperience working with and effectively influencing cross-functional partners (i.e., Marketing, Health Economics, Regulatory Affairs, Clinical Affairs, Business)Experience working with clinician KOLs, regulatory agencies, and external consultantsFundamental knowledge of global clinical and regulatory requirements related to clinical study design and executionDemonstrated project planning and leadership, critical thinking, and problem-solving skillsStrong verbal and written communication skills in scientific and/or clinical disciplinesDemonstrated ability to develop deep understanding of clinical pathologies and clinical dataDemonstrated ability to critically research, synthesize, analyze, and appraise a breadth of scientific and medical literatureDemonstrated ability to work independently and in a group in a manner that is collaborative and productiveAbility to travel up to 15%
Desired Qualifications:Master's degree, PhD, or equivalent advanced degreeBasic understanding of biostatistics
This position requires access to export-controlled areas and information. Candidates must be "U.S. persons" as that term is defined in 8 USC *1324b(a)(3). The term "U.S. persons" includes resident aliens ("green-card" holders) as well as certain refugees, asylum-holders and residents qualifying for temporary residence under the terms of 8 USC *1255a.Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).What We Offer:
Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefitsWe believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact#LI-Hybrid#LI-REMOTE