Sr. Manager, Clinical Management, Early Phase: Immunology/Auto-immune

Otsuka America Pharmaceutical Inc.; Annapolis (MD); On-site; USD 180,000 - 230,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager of Clinical Management to oversee early phase immunology/autoimmune studies (P1-2a).

You will coordinate with internal teams and external partners to plan, execute, and complete trials in compliance with ICH GCP and Otsuka SOPs. The role requires leadership to guide clinical staff, manage vendor relationships, and ensure budgets and timelines are met across portfolios.

Qualifications

• Ability to oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of CROs, outsourcing, and evaluation of vendor SOWs.
• Strong understanding of clinical and scientific basis for assigned program and its operational translation.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical and leadership skills.

Responsibilities

• Provide oversight and management of Otsuka early phase clinical studies (P1-2a).
• Coordinate development and review of critical study documents (protocols, ICFs, etc.).
• Assess and select CROs and ESPs and manage external vendors and sites.
• Lead and guide clinical team to ensure compliance with ICH GCP and SOPs.
• Communicate study progress, budget, and resource needs across cross-functional groups.
• Support forecasting of expenditures and resourcing; monitor budget variances.

Skills

SAD/MAD/POC Trials

CRO Oversight

Regulatory Knowledge

People Management

Operational Management

Job description

Sr. Manager, Clinical Management, (Early Phase: Immunology/Auto-immune)

Job Summary

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka EARLY PHASE (P1-2a) clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.

Job Description

• Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.
• Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.
• Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
• Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.
• Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.
• Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
• Participate in forecasting study expenditures and resourcing needs.
• Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.
• Provide timely communication of any variances in budget forecast to the Director/Associate Director.
• Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
• Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.
• Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.
• Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.
• Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.
• Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.
• Represent Clinical Management in departmental and cross-functional initiatives, as assigned.
• Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.
• May have supervisory responsibilities including:
  • Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
  • Assuring compliance with departmental, SOP, compliance, and corporate training
  • Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
  • Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.
• Performs other duties, as assigned.

Qualifications / Required

Knowledge/ Experience and Skills:

• Ability to oversee complex (ie basket trials) First in Human SAD/MAD/POC trials in immunology/autoimmune indications
• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).
• Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical, problem solving, and people management skills