Chief Development Officer, Rare Disease (Boston)

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

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.