Senior Director, Clinical Operations

🔥 14 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $175k - $195k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Alira Health

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.

📋 Description

• 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. • In charge of 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. • Responsible for oversight of CMC team, consultants, development, manufacturing operations, supply chain activities, and external CDMO relationships. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Professional development • Global travel • Flexible work programs