Remote Director: Early-Phase Clinical Management

Otsuka America Pharmaceutical Inc.; Hartford (CT); Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Generous paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy and management of clinical programs.

You will coordinate with internal departments and ESPs to plan, execute, and complete studies in compliance with ICH, GCP, and SOPs within budget and timelines. Responsibilities include developing the Global Clinical Development Plan, leading teams, and supporting regulatory submissions.

Qualifications

• Comprehensive knowledge of clinical operations, drug development process, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of SOW.
• Advanced understanding of drug development and clinical trial management.
• Strong regulatory, biostatistics, data management, and medical writing knowledge.
• Excellent communication, organization, planning, analytical and leadership skills.
• Proficient with MS Office and trial software like eCRFs, IRT, CTMS.
• Ability to travel up to 25%.

Responsibilities

• Provide scientific clinical research and operational expertise for Global Clinical Development Plan.
• Oversee development of Clinical Development Plan timelines and budgets for opportunities.
• Ensure program-wide standards across studies for consistency of clinical dossiers.
• Contribute to clinical trial reports, publications, and presentations.
• Lead program-level teams as Co-Chair or lead clinical management representative.

Skills

Clinical operations

GCP/ICH regulations

CROs & SOW

Regulatory compliance

Biostatistics

Data management

Medical writing

Leadership

Travel readiness

Education

Bachelor's degree with 14+ years pharma

Advanced degree

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy and management of clinical programs.

You will coordinate with internal departments and ESPs to plan, execute, and complete studies in compliance with ICH, GCP, and SOPs within budget and timelines. Responsibilities include developing the Global Clinical Development Plan, leading teams, and supporting regulatory submissions.