Senior Manager, Clinical Management – Early Phase, Immunology/Auto-immune

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

📋 Description

• Oversee and manage early-phase (P1–2a) clinical trials.

• Plan, execute, and finalize clinical studies in accordance with relevant regulations, ICH/GCP guidelines, and Otsuka SOPs.

• Contribute to the development and review of clinical study documents, protocols, and informed consent forms.

• Provide insights for the identification, evaluation, and selection of CROs, external vendors, and investigative sites.

• Lead and direct the clinical team to ensure compliant completion of study activities.

• Facilitate communication and coordination of project activities and progress across various departments.

• Update management on scope, schedule, and resource allocation.

• Engage in forecasting study costs and resource requirements.

• Ensure study budgets and expenditures align with forecasts and report any discrepancies.

• Establish effective communication channels with CROs and investigative sites to enhance protocol adherence.

• Oversee daily trial operations for ESP.

• Review clinical trial data to ensure integrity, identify trends, and maintain consistency.

• Support inspection readiness and ensure the completeness, timeliness, and quality of the TMF.

• Represent Clinical Management during protocol reviews and in departmental or cross-functional initiatives.

• Participate in risk mitigation activities at both the program and study levels.

• Lead or assist in standardization and continuous improvement initiatives.

• Coordinate training and onboarding processes for new employees as assigned.

• Set performance expectations and development plans, providing feedback to employees when assigned.

• Perform other duties as assigned.

⛳️ Requirements

• Ability to manage complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.

• Extensive knowledge of clinical operations, drug development processes, project team roles and responsibilities, SOPs, and GCP/ICH regulations.

• In-depth understanding of CROs, outsourcing practices, and the evaluation of work against vendor Statements of Work (SOW).

• Strong grasp of the clinical and scientific foundations of the assigned clinical program, with the ability to translate this knowledge into operational management.

• Solid understanding of global regulatory standards.

• Excellent communication, organization, planning, analytical, problem-solving, and people management skills.

• Proven experience with Microsoft Office programs, including Word, Excel, PowerPoint, and Outlook.

• Familiarity with clinical trial software, including eCRFs, IRT, and CTMS.

• Willingness to travel up to 25% of the time.

• Bachelor’s Degree or Registered Nurse (RN) qualification.

• Minimum of 10 years of industry experience, with at least seven years in clinical trial management.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement program.

• Student loan assistance.

• Generous 401(k) matching program.

• Flexible time off policies.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Incentive opportunities.