Director of Clinical Programs & Strategy

Otsuka America Pharmaceutical Inc.; Atlanta (GA); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Tuition reimbursement

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director to manage operational strategy and oversight of clinical programs in collaboration with the Senior Director of Clinical Management.

The role spans planning, execution, and completion of programs in compliance with GCP, ICH and SOPs within timelines and budget. The position requires extensive leadership of global clinical development, collaboration with ESPs, CROs and cross-functional teams to optimize trial design, data quality and publication

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and vendor SOW evaluation.
• Advanced understanding of drug development principles and trial management.
• Strong regulatory, biostatistics, data management and medical writing knowledge.
• Excellent communication, organization and leadership skills.
• Willingness to travel up to 25%.

Responsibilities

• Provide scientific clinical research and operational input for the Global Clinical Development Plan.
• Represent Clinical Management in development of timelines and budgets for clinical opportunities.
• Ensure program standards are applied across studies to ensure dossier consistency.
• Contribute to clinical trial reports, publications and presentations.
• Develop program-level financial estimates and MLTP contributions.
• Lead program teams as Co-Chair or lead clinical management representative in meetings.

Skills

Clinical operations

GCP/ICH

Vendor management

Leadership

Communication

Travel up to 25%

Education

Bachelor’s Degree with pharma experience

Advanced Degree (preferred)

Tools

MS Office

eCRFs/IRT/CTMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Director to manage operational strategy and oversight of clinical programs in collaboration with the Senior Director of Clinical Management.

The role spans planning, execution, and completion of programs in compliance with GCP, ICH and SOPs within timelines and budget. The position requires extensive leadership of global clinical development, collaboration with ESPs, CROs and cross-functional teams to optimize trial design, data quality and publication