What are the responsibilities and job description for the Senior Director, Clinical Affairs position at Edwards Lifesciences?
Senior Director, Clinical Affairs (Remote)- Surgical Structural Heart Medical & Clinical Affairs
This is a unique and challenging opportunity to join Edwards Surgical Structural Heart Medical & Clinical Affairs team to deliver trusted clinical data and scientific leadership to promote the success of our Surgical Portfolio and future innovations.
We have an outstanding leadership opportunity with our Surgical Structural Heart team for a Senior Director of Clinical Affairs , this dynamic leader will play a critical role in the clinical study execution, assist in developing clinical strategy, and manage legacy studies leading a team of Clinical Trial Program Directors.
Key Responsibilities include, but not limited to:
- Direct clinical activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through manager(s) and/or experienced professionals. Develop a robust talent development and succession planning in alignment with functional growth strategies across the clinical organization
- Oversee the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards' research programs
- Analyze, formulate, and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication
- Mitigate/eliminate risk, direct and communicate highly complex projects, initiatives and/or strategies which includes negotiations with internal and external parties
- Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams including but not limited to:
- Ensure on time execution of clinical trials in accordance with global clinical processes, regulations and good clinical practices
- Effectively partner with internal team members to drive clinical trial success across multiple functions
- Provide strategic leadership and direction including the development and maintenance of significant KOL relationships
- Key stakeholder in Scientific Communication activities: clinical data reports, presentations for Regulatory submissions, conferences, and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees) and ensure accuracy and relevancy
Minimum Education and Experience *:
- Bachelor's Degree in related field, required
- Minimum of 15 years of extensive experience in clinical strategy, clinical design, trial management in either medical device/sponsor/ CRO/ Healthcare/Academic industry, required
- Minimum of 5-8 years of direct people management experience, demonstrated track record of strong leadership and coaching ability across multiple geographies, required
- Prior clinical research experience with Class II and Class III Medical Devices including IDE and 510k is, required
- Ability to travel up to 40% for meetings and conferences
- Covid vaccination, required
Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:
- Master's degree, or PhD, or other advanced degrees
- Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure areas
- Experience in managing clinical trial steering committees and involvement in clinical, regulatory, and marketing aspects of medical device technology
Additional Required Skills:
- 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
- Exceptional 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 looking beyond existing methodologies and own discipline to define and resolve complex problems
- Excellent financial and business acumen
- Expert understanding and application of industry best practices
- Demonstrated ability to direct 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
- Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions
- Knowledge of biostatistical and actuarial methods
- 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
- Interacts with senior management, and others concerning matters of significance to the company
- Conduct business and technical briefings for senior and top management and for external representatives
- Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
- 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 large 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 within the organization
- 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.
The base pay range for this position is $184,000 to $235,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.
This is a unique and challenging opportunity to join Edwards Surgical Structural Heart Medical & Clinical Affairs team to deliver trusted clinical data and scientific leadership to promote the success of our Surgical Portfolio and future innovations.
We have an outstanding leadership opportunity with our Surgical Structural Heart team for a Senior Director of Clinical Affairs , this dynamic leader will play a critical role in the clinical study execution, assist in developing clinical strategy, and manage legacy studies leading a team of Clinical Trial Program Directors.
Key Responsibilities include, but not limited to:
- Direct clinical activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through manager(s) and/or experienced professionals. Develop a robust talent development and succession planning in alignment with functional growth strategies across the clinical organization
- Oversee the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards' research programs
- Analyze, formulate, and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication
- Mitigate/eliminate risk, direct and communicate highly complex projects, initiatives and/or strategies which includes negotiations with internal and external parties
- Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams including but not limited to:
- Ensure on time execution of clinical trials in accordance with global clinical processes, regulations and good clinical practices
- Effectively partner with internal team members to drive clinical trial success across multiple functions
- Provide strategic leadership and direction including the development and maintenance of significant KOL relationships
- Key stakeholder in Scientific Communication activities: clinical data reports, presentations for Regulatory submissions, conferences, and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees) and ensure accuracy and relevancy
Minimum Education and Experience *:
- Bachelor's Degree in related field, required
- Minimum of 15 years of extensive experience in clinical strategy, clinical design, trial management in either medical device/sponsor/ CRO/ Healthcare/Academic industry, required
- Minimum of 5-8 years of direct people management experience, demonstrated track record of strong leadership and coaching ability across multiple geographies, required
- Prior clinical research experience with Class II and Class III Medical Devices including IDE and 510k is, required
- Ability to travel up to 40% for meetings and conferences
- Covid vaccination, required
Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:
- Master's degree, or PhD, or other advanced degrees
- Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure areas
- Experience in managing clinical trial steering committees and involvement in clinical, regulatory, and marketing aspects of medical device technology
Additional Required Skills:
- 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
- Exceptional 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 looking beyond existing methodologies and own discipline to define and resolve complex problems
- Excellent financial and business acumen
- Expert understanding and application of industry best practices
- Demonstrated ability to direct 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
- Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions
- Knowledge of biostatistical and actuarial methods
- 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
- Interacts with senior management, and others concerning matters of significance to the company
- Conduct business and technical briefings for senior and top management and for external representatives
- Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
- 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 large 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 within the organization
- 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.
The base pay range for this position is $184,000 to $235,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.
Senior Director, Regulatory Affairs - Advertising & Promotion
Clinical Dynamix -
Morris, NJ
Senior Director, Regulatory Affairs - Advertising & Promotion Job at Clinical Dy
Clinical Dynamix, Inc. -
Morristown, NJ
Senior Director, Clinical Affairs
J&J Family of Companies -
San Jose, CA
