Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety 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 evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

　　Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

　　As the Sr. Clinical Contracts (Vendors & Suppliers) Manager for our THV team, you will be responsible for the full clinical contract lifecycle including partnering closely with clinical study teams, hospitals, vendors, consultants, Legal, Finance and Compliance groups to develop and lead the execution of a variety of clinical contracts while applying legal and clinical expertise.

　　The position will be on-site at our Irvine headquarter 5 days/week and will turn to a hybrid working schedule after the completion of the first 6 months.

　　How you will make an impact:

　　Manage and oversee the work of assigned team(s) within own function; develop and foster a robust talent development plan in alignment with functional growth strategies of the department and business unit; train and coach lower-level employees on moderately-complex clinical and/or contracts matters; monitor staff’s progress (e.g., follow-up and output) to ensure that contracts analysts are following up with their assigned sites and/or vendors in the timelines identified by leadership

　　Draft, negotiate, and execute the full clinical contract lifecycle for a variety of moderately-complex contract types at high quality (e.g., clinical trial agreements including budgets, non-disclosure agreements, and/or vendor contracts including RFP process), utilizing appropriate Edwards & third-party systems); assess needs for moderately- complex contract and budget amendments and provide guidance to stakeholders, make recommendations, and/or negotiate changes to terms and conditions while mitigating risks to the company

　　Plan and direct moderate to complex clinical contracts projects and activities with large scale or moderately significant business impact with the accountability for successful and timely completion of all deliverables

　　Identify and mitigate risks with moderate to high exposure to the company and create corrective action plans to prevent repeat of risks; ecalate contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders, and suggest solutions

　　Develop budgets (e.g. study and/or vendor) of moderate complexity based upon fair market value assessments with in-depth understanding of clinical project scope in collaboration with clinical study teams

　　Provide input on legal-owned contract templates

　　May act as a department representative for special project and core/study team meetings

　　What you will need (Required):

　　Bachelor's Degree in related field PLUS 10 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes

　　3-4 years of leadership/people management experience

　　What else we look for (Preferred):

　　Master’s Degree or Juris Doctor PLUS 8 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes

　　Experience in healthcare related (clinical, HCP) contracts

　　Experience working in a regulated industry

　　Experience in managing contract system change

　　Additional skills:

　　Proven successful project management leadership skills

　　Proven expertise in Microsoft Office Suite and related tools and systems

　　Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

　　Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

　　Strict attention to detail

　　Ability to interact professionally with all organizational levels

　　Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

　　Ability to frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team

　　Participate and present at meetings with internal and external representatives

　　Resolve operational and scheduling issues

　　Dedicated to quality client service and pro-active and responsive to client needs

　　Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness

　　Ability to develop relationships and leverage them to influence change

　　Support and solicit input from team members at all levels within the organization

　　Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

　　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.

　　For California, the base pay range for this position is $115,000 to $163,000 (highly experienced).

　　The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

　　Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

　　Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

　　For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.