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 Senior Manager, Clinical Contracts and Budgets, you will be responsible for the full clinical contract and budget negotiation lifecycle, partnering closely with clinical study teams, hospitals, consultants, and cross‑functional groups such as Legal, Finance, and Compliance to develop, negotiate, and lead the execution of a wide range of clinical contracts and budgets while applying both legal and clinical expertise.
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine corporate location and have the ability to commute on required onsite days.
How you'll make an impact:
- Managing and overseeing the work of assigned team(s) within own function. Creating and fostering a robust talent development plan in alignment with functional growth strategies of the department and BU. Training and coaching lower-level employees on moderately complex clinical and/or contracts matters. Monitoring 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.
- Drafting, negotiating, and executing 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). Assessing needs for moderately complex contract and budget amendments and providing guidance to stakeholders, making recommendations, and/or negotiating changes to terms and conditions while mitigating risks to the company.
- Developing trial budgets of moderate complexity based upon fair market value assessments with in-depth understanding of clinical protocols in collaboration with clinical study teams.
- Planning and directing 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.
- Identifying and mitigating risks with moderate to high exposure to the company and creating corrective action plans to prevent repeat of risks. Escalating contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders, and suggesting solutions.
- Providing input on legal-owned contract templates.
What you'll need (Required):
- Bachelor’s degree or equivalent in related field with previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes or equivalent work experience based on Edwards criteria.
- Ability to travel up to 5% domestically.
What else we look for (Preferred):
- 10+ years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts.
- Certified Paralegal (CP) or contract certification.
- Experience in healthcare related contracts.
- Demonstrated track record in people management.
- Experience working in a regulated industry.
- 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 interact with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leading a cooperative effort among members of a project team.
- Ability to participate and present at meetings with internal and external representatives.
- Ability to resolve operational and scheduling issues.
- Dedicated to quality client service and pro-active and responsive to client needs.
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 $121,000 to $171,000 (highly experienced)
The pay for the successful candidate will depend on various factors (e.g., 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.
