Senior Director, Clinical Operations

🕒 vor 1 Monat

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $175.000 - $195.000 / Jahr

⏰ Vollzeit

🟠 Senior

🏥 Manager Klinischer Studien

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

👻 Geisterscore 0%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Alira Health

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🏥 Gesundheitswesen

🏭 Fertigung

⚕️ Krankenversicherung

💰 €58.000.000 Venture Round im 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Alira Health ist eine global tätige Unternehmensberatung, die mit Life-Sciences-Unternehmen zusammenarbeitet, um innovative Lösungen im Gesundheitswesen zu entwickeln. Das Unternehmen ist auf ein breites Spektrum an Dienstleistungen spezialisiert, darunter Forschung und klinische Entwicklung, Regulatory Compliance und Managementberatung. Alira Health konzentriert sich auf Patient Engagement, Market Access und praxisnahe Lösungen zur Verbesserung der Behandlungsergebnisse. Das Unternehmen ist dem Umweltschutz verpflichtet und engagiert sich aktiv in gesellschaftlichem Engagement und ESG-Initiativen. Zudem bietet Alira Health Technologielösungen mit dem Fokus, die Life-Sciences-Forschung durch Empathie und wissenschaftliche Exzellenz voranzubringen.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• Professional development • Global travel • Flexible work programs