Global Clinical Research Strategist

Company: W.L. Gore & Associates
Location: Flagstaff
Posted on: November 18, 2024

Job Description:

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 position will be located at any Gore Medical facility in Flagstaff or Phoenix, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

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 designs
• Identify 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 outcomes
• Develop, 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 strategy
• Develop and document clinical study design rationales
• Provide 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 selection
• Develop 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 appropriate
• Maintain 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 applications
  • Experience 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 consultants
  • Fundamental knowledge of global clinical and regulatory requirements related to clinical study design and execution
  • Demonstrated project planning and leadership, critical thinking, and problem-solving skills
  • Strong verbal and written communication skills in scientific and/or clinical disciplines
  • Demonstrated ability to develop deep understanding of clinical pathologies and clinical data
  • Demonstrated ability to critically research, synthesize, analyze, and appraise a breadth of scientific and medical literature
  • Demonstrated ability to work independently and in a group in a manner that is collaborative and productive
  • Ability to travel up to 15%
    
    Desired Qualifications:
    
    • Master's degree, PhD, or equivalent advanced degree
    • Basic 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.
      
      Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.
      
      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/benefits
      
      We 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

Keywords: W.L. Gore & Associates, Prescott , Global Clinical Research Strategist, Healthcare , Flagstaff, Arizona