Company Description
St. Jude is where those with a passion for making a difference come to break new ground. Located in Memphis, Tennessee, the mission of St. Jude Children’s Research Hospital is to advance cures, and means of prevention, for pediatric catastrophic diseases through research and treatment. We are leading the way the world understands, treats and defeats childhood cancer and other life-threatening diseases.
Position Overview
The Head of Regulatory Sciences & Quality Management, Innovation Management & Industry Engagement is an integral member of St. Jude’s Innovation Management & Industry Engagement Team. The team’s purpose is to support St Jude’s mission to reduce the burden of catastrophic pediatric diseases by making innovations accessible. All team members are responsible for stewardship of translation of the organization’s innovations. The team is responsible for leading the translation of innovations to the market through industry partners, licensees, or other reputable organizations capable of making innovations accessible in a timely, efficient, and reliable manner. The team is also responsible for leading engagements with industry along the innovation continuum from early scientific research collaborations to later stage transactions, assessing the market viability of St Jude’s innovation pipeline, prioritizing the translation of innovations that meet the organization’s mission, and pursuing pathways for translation of innovations that most effectively enable accessibility. The team holds responsibility for pursuing pathways for translation of innovations that most effectively enable accessibility, portfolio management and progress monitoring to oversee timely and efficient translation of innovations, tracking metrics to continually improve innovation management and industry engagement processes, and education and communication of innovation management and industry engagement.
The Head of Regulatory Sciences & Quality Management, Innovation Management & Industry Engagement is responsible for leading comprehensive regulatory strategies to enhance the organization’s efforts to make technologies, innovations, and science developed at St. Jude broadly accessible. Expertise in new product development, global regulatory pathways, quality assurance, cross-functional market readiness, strategic planning, and partner management will be critical in promoting St. Jude’s world-class innovations to a diverse audience.
Other projects and assignments, as required.
This position may be eligible for the possibility of remote work.
Job Responsibilities:
• Lead a team that effectively manages the regulatory processes for the Innovation Management & Industry Engagement Team in support new product development intended for market translation pathways.
• Lead a team that is responsible for quality assurance framing, certification, and sustained compliance for the Innovation Management & Industry Engagement Team for technologies intended for market translation pathways.
• Collaborate with leadership and cross-functional affiliates to drive continuous improvement in product development processes, methodologies, and tools to enhance efficiency and effectiveness.
• Closely collaborate with St. Jude’s Regulatory and Clinical Departments, ensuring consistency with established policies and pathways.
• Oversee development of effective regulatory strategies, least-burdensome approaches to technology authorizations pathways, and possible competitive blocking-strategies to strengthen product development.
• Work closely with researchers and associated teams early to develop regulatory strategies that enhance the market potential for technologies.
• Maintain adequate compliance for the Innovation Management & Industry Engagement Team in activities undertaken to advance technologies intended for market translation pathways.
• Identify potential risks and challenges associated with new product initiatives and develop mitigation strategies.
• Ensure new product development strategies are in alignment with established organization goals and objectives.
• Establish performance/compliance metrics to quantify success of new product development outcomes.
• Provide input into overall budget and expense management control for functional initiatives.
• Interface with Legal and Compliance teams to confirm strategic direction, risk-mitigation, and compliance maintenance.
• Actively drive processes for team management in terms of goalsetting, performance, development, and engagement.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• High ethical standards, integrity and strength of character in his/her personal and professional dealings and a willingness to act on and be accountable for his/her decisions.
• Maintains regular and predictable attendance.
Minimum Education and/or Training:
• Bachelor’s degree required.
• M.S., PhD, or MBA preferred.
Minimum Experience:
• Twenty (20) years’ experience in life sciences industry experience including ten (10) years’ experience in an executive role.
• Twenty (20) years of professional involvement in the device, pharmaceutical and/or biotechnology industry, with considerable experience with regulatory affairs leadership, and direct QMS framing, implementation, and maintenance oversight.
• Twenty (20) years of experience in strategic regulatory sciences & QMS framing/implementation/oversight, new technology development, portfolio management, and senior compliance leadership.
• Twenty (20) years of professional involvement in the device, pharmaceutical and/or biotechnology industry, with a demonstrable history of technology authorization.
• Ten (10) years of direct interaction with US and global regulatory authorities setting regulatory strategies and remediating compliance matters, as applicable.
• Prior experience building, staffing and leading an emerging technology-driven organization.
• Well-developed scientific expertise and a proven track record of successful product development, resulting in product regulatory authorizations.
• Excellent knowledge of current regulatory standards, and expertise in drug/device/biologics desired.
• A demonstrated ability to effectively interface with the leadership team, investors, and entrepreneurs.
• Leadership experience with a track record of moving products through the authorization process, including fast-track designations, rare-disease/orphan-drug, and priority review applications and approvals.
• Collaboratively lead and work alongside remote teams and be forward thinking, strategic and decisive in nature.
• Proactive, effective communicator with team, peers and senior leaders, both internally and with external collaborators.
• Knowledge of how people/organizations work and ability to apply that knowledge to influence, lead change, deliver strong results and build the confidence of stakeholders.
Special Skills, Knowledge and Abilities:
• Demonstrable experience leading strategic regulatory projects/processes from initiation to completion, including resource management, and collaboration with internal cross-functional teams and external partners preferred.
• Work hard and are not afraid to have a little fun while you do so.
• Setting Strategy: The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization’s overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and expand the boundaries within the industry.
• Executing for Results: Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• A prudent risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.
• A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization.
• Proactively tracks industry trends and emerging regulatory/compliance practices.
• Proactively builds and maintains key relationships within and outside the organization.
• Relationships and Influence: Demonstrates confidence in others, is team-focused, and celebrates success.
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in their beliefs, and active drive. Creates a sense of purpose/meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole.
Diversity, Equity and Inclusion
St. Jude Children’s Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world—regardless of race, religion or a family’s ability to pay. Learn more about our history and commitment.
Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.
St. Jude is an Equal Opportunity Employer
No Search Firms
St. Jude Children’s Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
Location: Memphis, TN, US
Job Posting Language: en
Qualifications:
- Bachelor’s degree required
- Twenty (20) years’ experience in life sciences industry experience including ten (10) years’ experience in an executive role
- Twenty (20) years of professional involvement in the device, pharmaceutical and/or biotechnology industry, with considerable experience with regulatory affairs leadership, and direct QMS framing, implementation, and maintenance oversight
- Twenty (20) years of experience in strategic regulatory sciences & QMS framing/implementation/oversight, new technology development, portfolio management, and senior compliance leadership
- Twenty (20) years of professional involvement in the device, pharmaceutical and/or biotechnology industry, with a demonstrable history of technology authorization
- Ten (10) years of direct interaction with US and global regulatory authorities setting regulatory strategies and remediating compliance matters, as applicable
- Prior experience building, staffing and leading an emerging technology-driven organization
- Well-developed scientific expertise and a proven track record of successful product development, resulting in product regulatory authorizations
- A demonstrated ability to effectively interface with the leadership team, investors, and entrepreneurs
- Leadership experience with a track record of moving products through the authorization process, including fast-track designations, rare-disease/orphan-drug, and priority review applications and approvals
- Collaboratively lead and work alongside remote teams and be forward thinking, strategic and decisive in nature
- Proactive, effective communicator with team, peers and senior leaders, both internally and with external collaborators
- Knowledge of how people/organizations work and ability to apply that knowledge to influence, lead change, deliver strong results and build the confidence of stakeholders
- Work hard and are not afraid to have a little fun while you do so
- Setting Strategy: The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy
- An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and expand the boundaries within the industry
- Executing for Results: Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations
- A prudent risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks
- A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization
- Proactively tracks industry trends and emerging regulatory/compliance practices
- Relationships and Influence: Demonstrates confidence in others, is team-focused, and celebrates success
- Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively
- An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in their beliefs, and active drive
- Creates a sense of purpose/meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole
Responsibilities:
- Lead a team that effectively manages the regulatory processes for the Innovation Management & Industry Engagement Team in support new product development intended for market translation pathways
- Lead a team that is responsible for quality assurance framing, certification, and sustained compliance for the Innovation Management & Industry Engagement Team for technologies intended for market translation pathways
- Collaborate with leadership and cross-functional affiliates to drive continuous improvement in product development processes, methodologies, and tools to enhance efficiency and effectiveness
- Closely collaborate with St
- Jude’s Regulatory and Clinical Departments, ensuring consistency with established policies and pathways
- Oversee development of effective regulatory strategies, least-burdensome approaches to technology authorizations pathways, and possible competitive blocking-strategies to strengthen product development
- Work closely with researchers and associated teams early to develop regulatory strategies that enhance the market potential for technologies
- Maintain adequate compliance for the Innovation Management & Industry Engagement Team in activities undertaken to advance technologies intended for market translation pathways
- Identify potential risks and challenges associated with new product initiatives and develop mitigation strategies
- Ensure new product development strategies are in alignment with established organization goals and objectives
- Establish performance/compliance metrics to quantify success of new product development outcomes
- Provide input into overall budget and expense management control for functional initiatives
- Interface with Legal and Compliance teams to confirm strategic direction, risk-mitigation, and compliance maintenance
- Actively drive processes for team management in terms of goalsetting, performance, development, and engagement
- Perform other duties as assigned to meet the goals and objectives of the department and institution
- High ethical standards, integrity and strength of character in his/her personal and professional dealings and a willingness to act on and be accountable for his/her decisions
- Maintains regular and predictable attendance
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