Senior Director, Clinical Operations

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as a key member of the Executive Leadership Team, contributing to the development of corporate strategies.

• Oversee the daily clinical operations of the company to ensure that strategic, developmental, and commercial goals are met effectively.

• Enhance organizational efficiency in clinical operations, promote cross-functional communication, and ensure accountability in execution.

• Create clinical operational plans that align with corporate growth, financing activities, partnerships, and strategic initiatives.

• Recognize clinical operational risks and establish strategies for mitigation.

• Responsible for providing executive oversight of clinical operations across all development programs.

• Ensure the efficient execution of clinical trials, including site activation, enrollment, monitoring, data management, safety reporting, and vendor oversight.

• Collaborate with Medical Development leadership to achieve program milestones and timelines.

• Guarantee compliance with GCP and relevant regulatory requirements.

• Supervise non-clinical development vendors and consultants, including activities related to pharmacology, toxicology, and bioanalytical projects.

• Ensure nonclinical studies are conducted in accordance with GLP requirements and development goals.

• Align nonclinical strategy with clinical, regulatory, and CMC functions to support development objectives.

• Provide strategic direction for regulatory planning and execution.

• Manage Regulatory Affairs leadership to support IND submissions, meeting requests, briefing packages, annual reports, and planning for marketing applications.

• Work closely with regulatory authorities and external advisors to further development programs and ensure compliance.

• Ensure development activities align with regulatory expectations and corporate objectives.

• Oversee Quality Assurance leadership and the company's quality systems and compliance processes.

• Ensure compliance with GCP, GLP, GMP, ICH guidelines, FDA regulations, and other applicable global standards.

• Foster a culture focused on quality, continuous improvement, and operational excellence.

• Oversee the CMC team, consultants, development, manufacturing operations, supply chain activities, and relationships with external CDMOs.

• Ensure the timely delivery of clinical supplies and initiate commercial supply planning according to timelines, budgets, and quality standards.

• Direct the CMC team in supporting process development, technology transfer, scale-up activities, and readiness for manufacturing.

• Continuously evaluate and mitigate risks associated with manufacturing and supply chains.

• Responsible for establishing, updating, and managing integrated development plans and cross-functional processes.

• Ensure synchronization of clinical, regulatory, quality, nonclinical, and manufacturing activities.

• Regularly monitor program timelines, contracts, budgets, resource allocation, and critical path activities.

• Lead program processes and executive portfolio reviews.

• Collaborate closely with the Chief Financial Officer and Finance team on budgeting, forecasting, and operational expenditures.

• Assist in annual planning processes and long-term strategic planning.

• Develop financial processes across operational functions.

• Implement outsourcing strategies and make resource allocation decisions.

• Contribute to Board presentations, investor discussions, due diligence activities, and business development initiatives.

• Cultivate and maintain productive relationships with CROs, CDMOs, consultants, academic institutions, investigators, and strategic partners.

• Assist in business development, public relations, alliance management, and partnership activities as required.

• Represent the company in dealings with investors, regulators, partners, and industry organizations.

⛳️ Requirements

• Advanced scientific degree (RN, PhD, PharmD, MD, MS) or equivalent experience is preferred.

• MBA or training in business management is strongly preferred.

• Over 10 years of progressive leadership experience in biotechnology, pharmaceutical, or life sciences organizations.

• Extensive experience managing multiple development functions, including clinical operations, regulatory affairs, quality, and manufacturing.

• Proven success in leading programs through IND-enabling activities and all clinical development stages (from Phase 0 to Phase III), along with regulatory interactions.

• Experience in operating within emerging-growth or publicly traded biotechnology companies is preferred.

• Demonstrated experience in managing outsourced development and manufacturing networks.

🏝️ Benefits

• Opportunities for professional development.

• Global travel opportunities.

• Flexible work programs.