Senior Manager, Clinical Contracts, Vendors/Suppliers - Edwards Lifesciences
Irvine, CA
About the Job
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 (Vendors & Suppliers) for our THV team, you will be responsible for the full clinical supplier contract lifecycle and ongoing management of HCP and non-HCP agreements; including partnering closely with internal stakeholders (clinical study teams, Legal, Finance, Compliance), third parties (clinical research organizations, vendors, consultants) to develop and manage the execution of a variety of clinical contracts while applying legal, contracting, and clinical expertise. The position will be on-site at our Irvine headquarters 5 days/week.
How you'll 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 complex vendor/supplier (HCP and non-HCP) contracts and budgets including analysis and negotiation (e.g., third-party clinical agreements, master service agreements, and/or “fee-for-service” vendor/supplier contracts including the RFP process), utilizing appropriate Edwards systems; assess need for complex contract and budget amendments and provide guidance to stakeholders, make recommendations, and/or negotiate pricing and changes to terms and conditions while mitigating risks to the company; conduct ongoing lifecycle management for suppliers, including new supplier onboarding, supplier qualification, COUPA activation/de-activation, annual supplier review/scorecards, and post-project reviews; collaborate with clinical stakeholders to identify and qualify new suppliers utilizing applicable Edwards’ systems (e.g., SmartSolve); draft RFP templates for new projects and analyze supplier bids, providing feedback and making recommendations to management and study teams; actively engage suppliers when deliverables and timelines are not aligned to contract obligations
+ Serve as project and/or subject matter expert (SME) for business unit and organizational initiatives; train, guide, and mentor team members on clinical and supplier contracts, site and supplier budgets, RFP process, EW policies, and EW systems
+ Identify and mitigate risks with moderate to high exposure to the company and create corrective action plans to prevent repeat of risks; escalate contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders, and suggest solutions
+ Provide input on legal-owned contract templates
+ May act as a department representative for special project and core/study team meetings
What you'll 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
+ Minimum 3 or more 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
+ 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
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
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). 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 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.
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 (Vendors & Suppliers) for our THV team, you will be responsible for the full clinical supplier contract lifecycle and ongoing management of HCP and non-HCP agreements; including partnering closely with internal stakeholders (clinical study teams, Legal, Finance, Compliance), third parties (clinical research organizations, vendors, consultants) to develop and manage the execution of a variety of clinical contracts while applying legal, contracting, and clinical expertise. The position will be on-site at our Irvine headquarters 5 days/week.
How you'll 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 complex vendor/supplier (HCP and non-HCP) contracts and budgets including analysis and negotiation (e.g., third-party clinical agreements, master service agreements, and/or “fee-for-service” vendor/supplier contracts including the RFP process), utilizing appropriate Edwards systems; assess need for complex contract and budget amendments and provide guidance to stakeholders, make recommendations, and/or negotiate pricing and changes to terms and conditions while mitigating risks to the company; conduct ongoing lifecycle management for suppliers, including new supplier onboarding, supplier qualification, COUPA activation/de-activation, annual supplier review/scorecards, and post-project reviews; collaborate with clinical stakeholders to identify and qualify new suppliers utilizing applicable Edwards’ systems (e.g., SmartSolve); draft RFP templates for new projects and analyze supplier bids, providing feedback and making recommendations to management and study teams; actively engage suppliers when deliverables and timelines are not aligned to contract obligations
+ Serve as project and/or subject matter expert (SME) for business unit and organizational initiatives; train, guide, and mentor team members on clinical and supplier contracts, site and supplier budgets, RFP process, EW policies, and EW systems
+ Identify and mitigate risks with moderate to high exposure to the company and create corrective action plans to prevent repeat of risks; escalate contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders, and suggest solutions
+ Provide input on legal-owned contract templates
+ May act as a department representative for special project and core/study team meetings
What you'll 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
+ Minimum 3 or more 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
+ 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
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
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). 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 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.
Source : Edwards Lifesciences