Director, Clinical Program Lead

Reporting to the Head of Clinical Operations, the Clinical Program Lead plays a pivotal role in shaping and driving clinical development programs from inception through regulatory submission. This role requires a versatile, resourceful professional with a proven ability to manage multiple responsibilities, adapt to changing priorities, and execute effectively in a lean organization. The Clinical Program Lead partners closely with internal and external stakeholders to ensure successful trial execution and program advancement.

Responsibilities

• Develops and executes the clinical operations strategy for assigned programs, ensuring alignment with corporate objectives and regulatory requirements.
• Leads cross-functional teams, fostering collaboration with internal and external stakeholders to deliver high-quality clinical trials on time and within budget.
• Oversees program operations, including protocol development, CRO and vendor management, study timelines, budgets, and quality metrics.
• Provides expert input on clinical documents, regulatory submissions, and key regulatory meetings (e.g., INDs, NDAs, BLAs, End-of-Phase 2 meetings).
• Monitors emerging clinical data, assesses risks, and adapts strategies to optimize outcomes.
• Builds and maintains relationships with key opinion leaders, investigators, and collaborators.
• Leads program-level oversight of strategic partners and vendors to ensure compliance with GCP/ICH guidelines and corporate standards.
• Manages and mentors Clinical Operations team members, providing training and leadership development.
• Identifies and drives process improvements to enhance clinical development efficiency and effectiveness.
• Communicates program status, risks, and mitigation plans to senior leadership, enabling informed decision-making.

Qualifications

• Bachelor’s degree or equivalent clinical experience required
• 7+ years of experience in clinical development, including leadership roles in biotech, pharma, or CRO settings, with at least 2 years in a startup environment
• Proven experience in early-phase clinical studies and/or late-phase global or international programs. Experience across multiple therapeutic areas is a plus.
• Strong expertise in clinical trial design, clinical operations, and regulatory requirements.
• Demonstrates adaptability, problem-solving skills, and a hands-on approach in a lean, fast-paced environment.
• Excellent leadership, organizational, and strategic thinking skills.
• Strong interpersonal and communication skills, with the ability to work cross-functionally and influence key stakeholders.
• Line management experience and mentoring abilities are advantageous.