Director, Clinical Program Management, Clinical Affairs

Director, Clinical Program Management, Clinical Affairs, Transcatheter Heart Valve (THV) Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions. The Transcatheter Heart Valve (THV) Clinical Affairs team is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide. We have an opportunity on the THV Clinical Affairs team for a Director, Clinical Program Management to manage clinical trial activities and to ensure all applicable regulatory requirements are met. This role is based on site at Edwards Lifesciences’ corporate headquarters in Irvine, California. Key Responsibilities: Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile, larger and more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s) Provide direction, guidance, and oversight of clinical core teams to execute high-profile, larger and more complex projects for multiple clinical studies and initiatives. Determine clinical trial resources and set priorities for projects Manage project status and appropriate communication both internally and externally including key opinion leaders. Present trial information at executive and/or industry conferences Analyze trial performance to plan and develop corrective actions. Anticipate and communicate study risks and lead in the implementation of mitigation strategies Build an effective and efficient clinical project team. Provide mentoring and coaching to other project team members. Oversee the selection of clinical vendors and study sites Manage and oversee the preparation of clinical portions of IDE and PMA submissions Other incidental duties Minimum Requirements: Bachelor's Degree in related field with 12 years related experience in clinical research, including project management Master's Degree in related field with 10 years related experience in clinical research, including project management Doctorate Degree in related field with 8 years related experience in clinical research, including project management Preferred Qualifications: Experience in CV medical device clinical research, particularly in mitral valve clinical studies Experience monitoring multiple clinical sites for IDE studies Experience managing multiple studies in multiple stages – at least 5 years of clinical study management experience highly preferred Experience leading investigator meetings Experience interfacing with clinical research staff Experience working in a large medical device company Experience working cross-functionally Experience reviewing and approving reports such as Annual Progress Reports, Clinical Study Reports Experience assessing the impact of clinical study risks and provide guidance on next steps Experience facilitating outside the box strategic thinking Additional Talents and General Expectations: Proven successful project management skills Proficient in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred 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 knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols Expert understanding of regulatory submissions, reporting, and audits Ability to manage confidential information with discretion Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Represents leadership on projects within multiple areas, interfacing with project managers, clinical team and middle management Consult in project setting within multiple areas, interfacing with low to middle management Provides leadership to outsourcing partners on a task level, participates on small scale RFP 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 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 $200,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). 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.

Salary : $141,000 - $200,000