Vice President/Global Head, Regulatory Affairs

Why join Cardurion Pharma?

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

The Role:

The VP, Global Head of Regulatory Affairs will be a key member of the R&D leadership team, responsible for leading the global regulatory organization. They will oversee and be accountable for the following functions: Regulatory Strategy, CMC Regulatory Affairs, and Regulatory Operations. This leader will be viewed as the “strategic partner” to and report directly to the Chief Medical and Scientific Officer, helping to determine the strategy and standards of operational excellence and implementation across clinical development and regulatory affairs.

Here’s What You’ll Do:

• A key member of the R&D leadership team, responsible for overseeing leadership of the global regulatory organization
• Oversee and be accountable for growing and leading a regulatory organization inclusive of the following functions: Regulatory Strategy, CMC Regulatory Affairs, and Regulatory Operations.
• This leader will be viewed as the “strategic partner” to and report directly to the Chief Medical and Scientific Officer helping to determine the strategy and standards of operational excellence and implementation across clinical development and regulatory affairs
• Works with program team members to establish regulatory strategies for development programs and provides insight and direction to the Business Development function, enabling them to refine their strategy and evaluate opportunities as they arise
• Proactively identifies potential strategic issues/opportunities and communicates potential risks associated with strategic scenarios
• Oversees and/or leads both clinical and CMC related regulatory agency interactions
• Monitors US, EU and Global regulations, and assesses any changes to ensure all development activities are in compliance with applicable current regulations and guidelines
• Develops strategies for complex issues with potential for significant regulatory compliance impact and ensures regulatory compliance of products through change control procedures
• Builds mutually respectful and collaborative working relationships with other key functions and motivates the group to the highest level of performance and quality
• Able to hold people accountable, provide thoughtful and accurate feedback; delegate appropriately, drive to develop and retain top talent
• Builds relationships and leads a cross functional team through influence. Achieves this influence and level of leadership through maintenance of the highest levels of integrity and trust.
• Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty
• Serves as the single point of contact for all regulatory interactions and remains current on all active programs
• Establishes clear responsibilities and processes for monitoring work and measuring results
• Actively seeks input from pertinent sources to make timely and well-informed decisions.

Here’s What We’ll Bring to the Table:

• Highly competitive benefits including: medical offered through BCBS PPO, Delta Dental, and vision offered through VSP
• Fully funded HSA for high-deductible PPO Plan
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 4 weeks Paid Time Off annually
• 10 company paid holidays and Year-End shut down
• 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately
• A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability

Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Here’s What You’ll Bring to the Table:

• Minimum of a Bachelor’s Degree in relevant area of study with an advanced degree preferred
• 15 years of experience in Global Regulatory Affairs, with a significant focus in cardiovascular diseases, and a track record of successful health authority interactions across all phases of drug development
• An experienced leader who has successfully worked in high performance cross-functional teams, worked in a matrix structure, with the ability to translate strategy into clear operational objectives
• Demonstrates managerial courage to lead teams through change, especially growth, and ensure all actions taken are in line with the Cardurion culture of respecting the individual
• Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements for pharmaceutical product development and approval in multiple key regions (ie US, EU, Japan)
• Excellent verbal and written communication skills and collaborative interpersonal skills
• Strategic mindset with the ability to anticipate future trends accurately and has a broad knowledge and perspective of regulatory implications on clinical development
• Sets aggressive but achievable goals and has high standards
• Lead and inspire the Regulatory Team to achieve strategic goals, fostering a collaborative and high-performance culture while ensuring alignment with the company’s vision and values.