Edwards Lifesciences Clinical Counsel, Sr. Manager in Irvine, California
The Clinical Counsel, Sr. Manager reports to the VP and Associate General Counsel, Global Regulatory and General Counsel of Transcatheter Heart Valve business and is accountable for advising and collaborating with the global business on a broad range of legal regulatory-related activities, including clinical research and development, clinical trials, clinical data requests, regulatory engagement strategy, and compliance with medical device regulations, including all applicable GCP requirements. As a dedicated strategic legal partner, this person interacts with leadership and other stakeholders from various cross-functional teams and has client responsibility on a broad range of company research-related activities and clinical development programs from early to post market surveillance. Ideal candidates have strong leadership skills and extensive experience providing legal regulatory -related legal support in the areas noted and in advising business stakeholders in all levels of an organization, including senior and executive management, as well as the ability to lead and/or play a significant role in special projects and on cross-functional teams dealing with complicated legal issues. The type of strategic counseling required at this level requires an appreciation of the immediate and long-term impact that legal decisions may have on the overall global business.
Key Job Responsibilities:
Provide (non-IP) legal advice and counsel on issues impacting clinical research and development such as informed consent, CRO arrangements, patient recruitment activities, contract arrangements with investigators, clinical research vendors, and other collaborative research groups, GCP matters, and many other legal aspects of regulatory compliance involved in medical device activities. Intellectual property advice and counsel is not in scope for this role
Utilize strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risk within areas of responsibility and formulate and communicate compliant and practical solutions that meet business objectives
Review, interpret, negotiate, and draft various clinical study-related agreements, clinical data transfers, and licensing agreements with academic institutions and strategic partners
Create and deliver effective training and other presentations to stakeholders and other members of the department on legal topics and other relevant subjects
Provide advice on clinical trial recruitment activities and programs, including review of materials, and will work with cross functional teams to develop appropriate and compliant strategies for interacting with healthcare providers, payors, and other stakeholders
Proactively identify the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents
Serve as part of matrixed teams involved in clinical trial-related activities and collaborate effectively, find common ground, and build alignment with relevant stakeholders
Partner with other members in the Legal and Compliance Departments to ensure consistency in approach across areas of the overall business and providing support for areas outside of their primary areas of responsibility as needed
Contribute to strategic planning with partners and colleagues to optimize the implementation of clinical studies and other medical research activities
Keep informed of new laws, regulations, and industry trends affecting the organization
Establish strong partnership relationships with global clinical teams, as well as key cross functional teams engaged in development activities characterized by a high-level of collaboration and mutual respect
Drive increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders
Lead and drive special projects and cross-functional teams that have a broader impact on the organization
Partner with Legal Department colleagues in executing and enhancing corporate and department objectives
Mentor and take an interest in developing other members of the team and department
Create transparent and reliable lines of communication with legal department leadership and business partners, ensuring that project developments are shared in a timely manner
Review and provide feedback on proposed regulation or legislation and assess impact on Edwards
Define, direct, and manage the work of outside counsel and other legal vendors
Be a trusted business partner serving as guardian of EW assets and reputation while advancing solutions for the benefit of all stakeholders.
Juris Doctor from ABA accredited law school
Minimum of 4 years of experience in clinical study advice within a reputable law firm or in-house legal department
Relevant industry experience (e.g., medical device, pharmaceuticals, etc.) or in highly regulated environments
Excellent analytical, detail-oriented, organized and information seeking skills
Excellent organization and time management skills
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization
Expert understanding of related aspects of legal processes and/or systems
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 manage competing priorities in a fast-paced environment
Ability to represent leadership on projects within multiple areas, interfacing with project managers, legal team and middle management
Ability to consult in a project setting within multiple financial areas, interfacing with low to middle management
Ability to provide leadership to outsourcing partners on a task level, participates on small scale RFP
Adhere to all EHS rules and requirements 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
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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility 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 or have a valid religious or medical exemption from being vaccinated.
Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!
For Colorado Residents Only:
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.
The base pay range for this position is $162,000 to $189,000.
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 or have a valid religious or medical exemption from being vaccinated.
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.
- Edwards Lifesciences Jobs