Global Clinical Research Strategist Job at W. L. Gore & Associates
About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
About the Role: The Clinical Affairs team is looking for a Global Clinical Research Strategist to join our team. In this role, you will develop product’s clinical research strategy that aligns to desired business outcomes to form the product’s clinical research program. Primary accountability is development of the overall clinical strategy that is translated into clinical study design(s), then ensuring clinical study conduct and data output is in alignment with the study design and the overall clinical strategy.
This position offers multiple work arrangements: on-site or hybrid at our Route 66 facility in Flagstaff, Arizona, or fully remote work allowed in most locations within the United States, 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 to form the clinical research program that aligns to the global clinical research strategy
- 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 study design and clinical research strategy, strategically applying that expertise to meet business needs and objectives
- 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, EU design dossiers, etc.), and to external consultants and Key Opinion Leaders (KOLs) regarding clinical study design, study data, and overall clinical research strategy
- Document clinical study design rationales/justifications and 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 and execution of a clinical study. This includes but is not limited to input and review of the following: clinical study protocol, clinical study reports, statistical analysis plan, case report form specifications, tables/listings/figures for reports, risk assessment documentation, site and investigator selection
- Develop and maintain knowledge on disease and treatment space, current and future directions of external clinical research environment, US and OUS guidance/regulations, competitor research activities, new developments within clinical trial design, etc. and update/evolve/reconcile 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
- 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 cross-functional partners (i.e., Marketing, Health Economics, Regulatory Affairs, Clinical Affairs, Business) on projects
- 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, 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:
- PhD or equivalent advanced degree
- Basic understanding of biostatistics
- Experience working with global cross-functional partners (i.e., Marketing, Health Economics, Regulatory Affairs, Clinical Affairs, Business) on projects
- 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. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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