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Boston-Remote, United States of America
Remote only
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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
Job Description
The Senior Director, Clinical Operations, is a key member of the Executive Leadership Team responsible for the strategic and operational leadership of the Company's clinical development operations. The Senior Director, Clinical Operations provides oversight of Clinical Development Operations, Nonclinical Development, Regulatory Affairs, Quality Assurance, Manufacturing/CMC Operations, and Program Management, while partnering closely with R&D, Finance, Investor Relations, Legal, and the CEO to ensure efficient execution of corporate objectives. This role is accountable for translating the clinical operations strategy into operational execution, driving cross-functional alignment, ensuring compliance with global regulatory requirements, maintaining operational excellence, and supporting the advancement of the Company's development pipeline from research through commercialization.
The ideal candidate will possess biotech or pharmaceutical industry background, demonstrated leadership across multiple clinical operations disciplines, and some experience in building and scaling clinical operations organizations in a fast-paced, dynamic environment.
KEY RESPONSIBILITIES:
Corporate Leadership & Strategic Operations
• 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.
Clinical Development Operations
• 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. The main focus is on the Phase 2a timely execution and progress according to established timelines.
• Partner with Medical Development leadership to ensure achievement of program milestones and timelines.
• Ensure adherence to GCP and applicable regulatory requirements.
Nonclinical Development
• 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.
Regulatory Affairs
• 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.
Quality Assurance & Compliance
• 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
Manufacturing, CMC & Supply Chain
• 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.
Program Management
• 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.
Financial & Business Operations
• 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
External Partnerships
• 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
Preferred Qualifications and Experience
Education and Experience
• 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.
Languages
EnglishEducation
Bachelor of Science (BS): Life SciencesContract Type
RegularSalary Range
The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.
