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.