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
Clinical Research certification
Direct people development experience
Clinical contracts management work experience from pharmaceutical, medical device, healthcare, and CRO organizations
Additional Skills:
Demonstrated track record in people management
Clinical operations, clinical budgeting, and/or clinical contracts experience
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
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
Expert understanding of contract negotiation and administration, and clinical research operations procedures and processes while identifying applications of functional knowledge and existing methodologies to complex problems
Expert knowledge of budget planning that relates to clinical research procedures
Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Expert understanding of healthcare regulatory requirements (e.g., CFR, GCP) and documents
Expert knowledge of clinical research and operations acumen
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
Lead briefings and technical meetings for internal and external representatives
Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
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 $141,000 to $180,000 (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.
COVID Vaccination Requirement
Edwards 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.