Remote Director: Early-Phase Clinical Strategy

Otsuka America Pharmaceutical Inc.; Richmond (VA); Remoto; USD 180.000 - 280.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

Dental coverage

Vision coverage

401(k) match

Tuition reimbursement

Paid holidays

Paid leave

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy across clinical programs, coordinating with ESPs and internal teams.

Responsibilities include planning, execution, and compliant completion within timelines and budgets, with leadership across program teams and regulatory submissions. The role emphasizes collaboration with senior leadership, trial design oversight, budget planning, and ensuring inspection readiness across assigned

Competenze

• Comprehensive knowledge of clinical operations and drug development.
• Thorough understanding of CROs, SOWs, outsourcing and vendor oversight.
• Advanced grasp of global regulatory requirements and biostatistics.

Mansioni

• Define and execute clinical programs aligned with GCDP and budgets.
• Coordinate with ESPs, other Otsuka departments, and stakeholders.
• Lead program teams as Co-Chair or lead clinical management representative.
• Develop regulatory documents and contingency plans for submissions.
• Ensure trial data integrity, reporting and publication readiness.
• Drive program-level HEOR strategy and endpoints where needed.

Conoscenze

Clinical operations

GCP/ICH regulations

Regulatory knowledge

Budget & forecasting

Leadership

Vendor management

Data interpretation

Communication

Formazione

Bachelor’s degree

Strumenti

MS Office

Clinical trial software (eCRFs, IRT, CTMS)

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy across clinical programs, coordinating with ESPs and internal teams.

Responsibilities include planning, execution, and compliant completion within timelines and budgets, with leadership across program teams and regulatory submissions. The role emphasizes collaboration with senior leadership, trial design oversight, budget planning, and ensuring inspection readiness across assigned