Our client is a commercial-stage biopharmaceutical company developing innovative therapies for cardiovascular diseases. They have asked us to assist them in their search for a Chief Development Officer, Rare Disease.

Responsibilities:

• Lead and oversee all aspects of clinical development, including clinical strategy, clinical operations, regulatory affairs, clinical quality, and program management
• Develop and execute integrated development plans that support progression from IND through Phase 3 and registration, aligned with the company’s commercial and scientific goals
• Serve as a key interface with global regulatory authorities to support INDs, CTAs, and regulatory interactions across multiple geographies
• Collaborate cross-functionally with R&D, Medical Affairs, Commercial, and CMC to ensure alignment and execution of development strategies
• Drive strategic planning and decision-making as a member of the executive leadership team, contributing to portfolio prioritization, investor communications, and corporate strategy
• Evaluate and manage external partnerships, CROs, and vendors to support clinical development objectives
• Ensure compliance with global regulatory standards and industry best practices, including GCP and ICH guidelines
• Support lifecycle management and label expansion strategies for approved products, including real-world evidence (RWE), HEOR, and post-marketing commitments

We seek candidates with the following qualifications:

• Medical degree required
• Must have 15+ years of experience in clinical development and regulatory strategy, including leadership roles in biotech or pharmaceutical companies
• Proven track record of advancing programs through early and late-stage clinical development, including successful regulatory submissions and interactions
• Deep understanding of global regulatory pathways for biologics and small molecules
• Experience leading cross-functional teams and managing complex development programs in a commercial-stage environment
• Familiarity with rare disease or immunology areas is highly desirable
• Strategic thinker with a strong execution mindset and ability to operate in a fast-paced, dynamic environment
• Collaborative leader who thrives in a matrixed organization and can influence across functions
• Strong communicator with executive presence and ability to engage with internal and external stakeholders, including regulators, partners, and investors
• Passionate about improving patient outcomes and advancing science through thoughtful, data-driven development

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.