Director, Clinical Contracts

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 undertreated. 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.

of our inspiring journey.

We are searching for a Director of Clinical Contracts to join Edwards Clinical Contracts team. As a Director of Clinical Contracts, you will oversee a team of clinical contracts professionals to ensure the full clinical contracts lifecycle.

This is a hybrid (Irvine office and remote blend) or onsite role. Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.

How you'll make an impact:

• Manage and oversee the end-to-end lifecycle of clinical site contracts, including budgets, for the THV Business Unit, driving timelines and deliverables in support of company and Business Unit goals. 

• Develop a robust talent development plan in alignment with functional growth strategies of the department and BU. Train and coach junior level employees on clinical operations, moderately-complex clinical contracts, budgets, and/or general contracts matters. Monitor staff’s progress (e.g., follow-up and output) to ensure that contracts analysts are following up with their assigned sites in the timelines identified by leadership.  Resource clinical studies appropriately, providing sufficient coverage for new and long-term, ongoing studies.

• Plan and direct complex clinical contracts projects and activities with large scale or significant business impact with the accountability for successful completion of all deliverables.

• Identify risk, develop and lead in the implementation of broad and more complex clinical contracts and budgeting strategies which may include negotiations with internal and external parties.  Advise study leaders and manager of any risks or site issues which may arise during the negotiation or management of contracts.

• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues including corrective action plants in collaboration with cross functional and/or matrix teams. Plan, develop and lead the implementation of continuous process improvement projects.

• Develop master study budget (e.g. per-patient research costs and ancillary fees) of high complexity based upon fair market value assessments with in-depth understanding of clinical project scope in collaboration with clinical study teams.

• Provide input on complex legal owned contract templates and partner with Legal Department to update templates, as applicable.

• Assess needs and partner with project teams for contract and budget amendments and provide guidance to key stakeholders, make recommendations, and/or negotiate changes, to terms and conditions while mitigating risks to the company.

• Draft, redline and negotiate complex agreements between Edwards and clinical research institutions for key and complex contract types (e.g. Non-Disclosure Agreements, Master Clinical Trial Agreements, Statements of Work) including budgets, as they relate to research sites, utilizing appropriate Edwards systems (e.g. Electronic Contracts Lifecycle Management System).

• Other incidental duties

What you'll need (Required):

• Bachelor's Degree in related field

• 12 years of related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes

What else we look for (Preferred):

• Master's Degree in related field

• Paralegal certification

• Cli