Edwards Lifesciences Sr Manager Clinical Affairs in Unterschleissheim, Germany
Provide leadership and clinical expertise in support of new product development and/or marketed products.
• Manage professionals and oversee the work of multiple projects and/or initiatives and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Identify risk, develop and lead in the implementation of broad and more complex projects, initiatives and/or strategies which may include negotiations with internal and external parties. Develop mitigation strategies, alternative solutions, resolve issues, etc. in collaboration with cross functional and/or matrix teams
• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables including but not limited to:
o Oversee the relationship management of physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals, research institutions and/or vendors
o Ensure compliance to applicable regulatory requirements including safety reporting and device related complications through appropriate oversight
o Oversee clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness
o Serve as a point of escalation for complex project issues (e.g., sponsor site interaction for IRBs, contract, and training)
o Oversee the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators
o Oversee the accuracy/effectiveness of device accountability
• Other incidental duties
Education and Experience:
Bachelor's Degree in in scientific or related discipline with related experience required and skill levels exceeding the requirements of the Manager Required and
Demonstrated track record in people management Required
Master's Degree or equivalent in in related fieldExperience working in a regulated industry Preferred
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas strongly Preferred
• Proven successful project management leadership skills with ability to meet deadlines on multiple projects
• Proficient in Microsoft Office Suite and related tools and systems (e.g., CTMS)
• Excellent facilitation and presentation skills
• 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
• Ability to establish relationships and manage communications with key clinical customers (e.g., physicians, nurses, administrators)
• Ability to work positively through confrontation and/or conflicting ideas
• Expert understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR) while identifying applications of functional knowledge and existing methodologies to complex problems
• Excellent financial and business acumen
• 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
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical affairs to the business
• Strict attention to detail
• Fully comply with all US and Global regulations, and SOPs in the execution of all job duties
• 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 stakeholders 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
• Support and solicit input from team members at all levels
• 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 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.