Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
The SVP, Global Head of Clinical Development and Regulatory Affairs will be a key member of the R&D leadership team, responsible for overseeing clinical development of neuroscience and hem/onc portfolio as well as leadership of the global regulatory organization. S/he will oversee and be accountable for an organization of ~100 FTEs globally across clinical development and regulatory affairs, inclusive of the following functions: late clinical development (Sleep/Neuroscience and Hematology/Oncology therapeutic areas), Regulatory Strategy, CMC Regulatory Affairs, Global Regulatory Labelling and Regulatory Operations..
This leader will be viewed as the "strategic partner" to and report directly to the Global Head of Research and Development, helping to determine the strategy and standards of operational excellence and implementation across clinical development and regulatory affairs.
Key responsibilities include:
- Lead and oversee an integrated clinical and regulatory affairs organization to drive and execute Jazz's clinical development strategy forward with an eye towards operational excellence, cross functional collaboration and innovation.
- Provide a vision of excellence in Clinical Development and Global Regulatory Affairs, in terms of standards, process and performance, and create and refine a clinical development strategy with a road-map for implementation.
- From a Governance perspective, take the lead in determining the most advantageous clinical development programs for the company, ensuring "buy-in" from the Executive Team and all key stakeholders. Will be a standing member the late Development Program review Committee and participate in other key governance bodies. Serve as Chair for Protocol Review Committee.
- Provide insight and direction to the Business Development function, enabling them to refine their strategy and evaluate opportunities as they arise.
- Support Global Regulatory Leadership team in establishing the team as strategic partners to development and commercial, bringing best-in-class processes, insights, and a solutions-oriented mindset to the regulatory process.
- Influences strategy to address internal or external business and regulatory issues. Proactively identifies potential strategic issues/opportunities.
- Oversee team members to establish development of Regulatory strategies for commercial products and late and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
- Oversee and/or lead both clinical and CMC related regulatory agency interactions.
- Monitor US, EU and Global regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
- Develop strategies for complex issues with potential for significant regulatory compliance impact. Ensure continued regulatory compliance of products though change control procedure.
- Represent Jazz Pharmaceuticals in various external forums as needed. Through outstanding communication skills, help to increase the profile of Jazz R&D.
- Build mutually respectful and collaborative working relationships with other key functions.
In terms of the performance and personal competencies required for the position, we would highlight the following:
- MD with minimum 15 years combined experience in Global Regulatory Affairs and Clinical Development, in at least two therapeutic areas across phase I-IV; has a track record of successful filings.
- An experienced leader who has successfully managed high performance cross-functional teams, worked in a matrix structure, with the ability to translate strategy into clear operational objectives.
- Demonstrate managerial courage to lead teams through change, especially growth, and ensure all actions taken are in line with the Jazz culture of respecting the individual.
- Led a multi-site, multi-function global organization of significant size and complexity. Able to hold people accountable, provide thoughtful and accurate feedback; delegate appropriately, drive to develop and retain top talent. Uses sound judgement in hiring decisions.
- Have the gravitas, confidence and executive presence to operate with business leaders. Be self-confident, but without ego. Have not only scientific credibility, but obvious business acumen.
- Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, EU, Japan).
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
- Demonstrated ability to coordinate global activities and has a track record in regulatory success is important.
- Excellent verbal and written communication skills and collaborative interpersonal skills.
In terms of the leadership competencies required for this position, we would highlight the following:
Anticipates future trends accurately and has a broad knowledge and perspective of regulatory implications on clinical development. Sees the big picture; able to articulately and succinctly paint credible pictures and visions of possibilities and probabilities to executive management. Inspires and motivates entire groups to the highest levels of performance and quality within the organization.
Driving for Results
Consistently achieves results, even under challenging circumstances. Sets aggressive but achievable goals and has high standards. Pursues everything with energy, drive, and the need to finish. Persists in the face of challenges and setbacks. Always keeps the end in sight; pushes self and helps others to achieve results.
Building Relationships and Using Influence
Ability to lead a cross functional team through influence. Achieves this influence and level of leadership through maintenance of the highest levels of integrity and trust. Builds and sustains excellent relationships at multiple levels within the organization and with external key stakeholders such as federal regulatory agencies, clinical investigators, academics, and others.
Decisively makes high-quality decisions, even when based on incomplete information in the face of uncertainty. Actively seeks input from pertinent sources to make timely and well-informed decisions. Skillfully separates opinions from facts and considers many perspectives objectively. Is respected by others for displaying superior judgement.
Deals comfortably with the uncertainty of change. Effectively handles risk. Is calm and productive, even when things are up in the air. Deals constructively with problems that may not have clear solutions or outcomes. Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty.
Assumes the responsibility for the outcomes of others. Promotes a sense of urgency and establishes and enforces individual and team accountability. Is completely on top of what is going on and knows where things stand. Provides balanced feedback at the most critical times. Establishes clear responsibilities and processes for monitoring work and measuring results.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.