Senior Director, Clinical Operations

Key Responsibilities

• Serve as a member of the Executive Leadership Team and participate in corporate strategy development.
• Lead day-to-day company clinical operations to ensure implementation and execution of strategic, development, and commercial objectives.
• Drive clinical operations organizational effectiveness, cross-functional communication, and execution accountability.
• Develop clinical operational plans to support corporate growth, financing activities, partnerships, and strategic initiatives.
• Identify clinical operational risks and implement mitigation strategies.
• Lead executive oversight of clinical operations activities across all development programs.
• In charge of efficient execution of clinical trials, including site activation, enrollment, monitoring, data management, safety reporting, and vendor oversight.
• Partner with Medical Development leadership to ensure achievement of program milestones and timelines.
• Ensure adherence to GCP and applicable regulatory requirements.
• Oversee non-clinical development vendors, consultants, activities, including pharmacology, toxicology, bioanalytical projects.
• Ensure nonclinical studies are executed in accordance with GLP requirements and development objectives.
• Coordinate nonclinical strategy with clinical, regulatory, and CMC functions to support development objectives.
• Provide strategic oversight for regulatory planning and execution.
• Supervise Regulatory Affairs leadership to support INDs, meeting requests, briefing packages, annual reports, and planning for marketing applications.
• Collaborate with regulatory authorities and external advisors to advance development programs and maintain compliance.
• Ensure alignment of development activities with regulatory expectations and corporate objectives.
• Oversee Quality Assurance leadership, company-wide quality systems and compliance processes.
• Responsible for compliance with GCP, GLP, GMP, ICH guidelines, FDA regulations, and other applicable global regulations.
• Promote a culture of quality, continuous improvement, and operational excellence.
• Oversee Manufacturing, CMC & Supply Chain activities.
• Ensure timely delivery of clinical supplies and initiate commercial supply planning in accordance with timelines, budgets, and quality requirements.
• Direct CMC team to support process development, technology transfer, scale-up activities, and manufacturing readiness.
• Continuously assess and mitigate manufacturing and supply chain risks.
• In charge of establishing, updating and managing integrated development plans and cross-functional processes.
• Ensure alignment of clinical, regulatory, quality, nonclinical, and manufacturing activities.
• Continuously monitor program timelines, contracts, budgets, resource allocation, and critical path activities.
• Lead program processes and executive portfolio reviews.
• Partner closely with the Chief Financial Officer and Finance team on budgeting, forecasting, and operational expenditures.
• Support annual planning processes and long-range strategic planning.
• Establish financial processes across operational functions.
• Implement outsourcing strategies and resource allocation decisions.
• Contribute to Board presentations, investor discussions, due diligence activities, and business development initiatives.
• Build and maintain productive relationships with CROs, CDMOs, consultants, academic institutions, investigators, and strategic partners.
• Support business development, PR, alliance management, and partnership activities as needed.
• Represent the Company in interactions with investors, regulators, partners, and industry organizations.

Qualifications

• Advanced scientific degree (RN, PhD, PharmD, MD, MS) or equivalent experience preferred.
• MBA or business management training strongly preferred.
• 10+ years of progressive leadership experience in biotechnology, pharmaceutical, or life sciences organizations.
• Significant experience overseeing multiple development functions, including clinical operations, regulatory affairs, quality, and manufacturing.
• Demonstrated success leading programs through IND-enabling activities, through all clinical stages of development (from Phase 0 to III), and regulatory interactions.
• Experience operating within emerging-growth or publicly traded biotechnology companies preferred.
• Proven experience managing outsourced development and manufacturing networks.