Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness, safety and value of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for developing the strategy to harness various data sources to answer essential scientific questions to increase access to pioneering technologies for patients in need. In close partnership with external stakeholders like KOLs,/HCPs, academic medical institutions, and regulatory authorities, you will support driving the evidence needed to optimize patient outcomes.Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.As the Director, Clinical Affairs (Clinical Data & Evidence Strategy), you will be responsible for developing and implementing innovative data strategies to generate and publish clinical outcomes and other evidence that showcases the value of Surgical’s portfolio. Support business growth and collaborate with stakeholders in Medical Affairs (including scientific communications) Global Health Economics and Reimbursement (GHER), Clinical Affairs., marketing etc.How you’ll make an impact:
Drive clinical data and real-world data strategies using third party and internal databases for clinical outcomes publication in high impact journals.
Manage development of multiple, global clinical study protocols, manage the process to obtain, evaluate, and resolve cross-functional input for document finalization to align with Business Unit strategic initiatives.
Evaluate and identify competitive outcomes research programs to understand clinical strategies.
Provide technical guidance and direction to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., protocols, etc.).
Research and evaluate literature and other data sources to compile applicable clinical inputs for the development of clinical study designs/synopses and provide recommendations on study endpoints.
Other incidental duties assigned by Leadership
What you’ll need (required):
Bachelor's Degree in related field with 12 years of related experience including 5+ years of medical writing and clinical data from 3rd party databases (i.e. EHR, MS, Optum, Truveta, Egnite, Huma, etc.) analysis
General knowledge of the coronary interventional and structure heart environments and current treatment options or have other clinical and/or clinical trial experience that fulfills this requirement
Ability to travel up to 20%
What else we look for (preferred):
Master’s Degree in scientific, technical or healthcare related field with 10 years of related experience including 5+ years of medical writing and clinical data from 3rd party databases (i.e. EHR, MS, Optum, Truveta, Egnite, Huma, etc.) analysis
Ability to develop clinical data collection and analysis protocol language and interpret and translate clinical, economic outcomes and results
Clinical data management skills, including data mining, data structures, data integration, data mapping, and data representation
Direct people development experience, including a remote workforce
Expertise in healthcare issues, and thorough understanding of med device industry data privacy rules/regulations including product developments, clinical literature review
Ability to review, assess and analyze the appropriate data sources to answer specific clinical questions and unmet needs preferred
Additional Skills:
Proven successful clinical project management skills
Expert understanding of relevant US and EU regulations and guidelines, Good Clinical Practice requirements and ICH guidelines.
Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)
Advanced editing and prooing skills
Excellent written and verbal communication skills including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills
Recognized as an expert in own sub-function(s) and/or area(s) within the organization with broad-based advanced knowledge within the organization
Expert knowledge and understanding of policies, procedures and guidelines relevant to medical writing styles and techniques
Expert knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
Expert product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
Exceptional knowledge of statistics and modeling
Strict attention to detail
Ability to interact professionally with all organizational levels including internal and external customers and proactively escalate issues to appropriate levels of management in the organization
Ability to consult in a project setting within multiple MACA areas, interfacing various levels of management
Ability to manage competing priorities in a fast-paced environment
Ability to represent leadership on projects within multiple areas, interfacing with project managers, cross-functional teams, and upper management
Ability to consult in a project setting within multiple clinical affairs areas, interfacing with low to middle management
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $166,000 to $235,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.