Director, Clinical Management: Strategy & Trials

Otsuka Pharmaceutical Co., Ltd; Rockville (MD); On-site; USD 186,489 - 278,875; Full time

Benefits offered by this job

Comprehensive medical coverage

401(k) match

Flexible time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Clinical Management in Rockville, MD. This role involves the operational strategy and management of clinical programs, ensuring compliance with regulations.

The ideal candidate will have a Bachelor’s Degree and a minimum of 14 years in the pharmaceutical industry, with at least 10 years in clinical trial management. Key responsibilities include managing teams and overseeing clinical trial operations, with a focus on data integrity and regulatory compliance.

Comprehensive benefits are offered, including medical, dental, vision, and generous leave policies.

Qualifications

• Comprehensive knowledge of clinical operations and GCP/ICH regulations.
• Advanced understanding of drug development principles.
• Strong knowledge of global regulatory requirements.

Responsibilities

• Manage operational strategy and clinical programs.
• Develop clinical program documents and ensure regulatory compliance.
• Lead program level teams and oversee clinical trial data integrity.

Skills

Clinical operations knowledge

Drug development process

Communication skills

Analytical skills

Problem-solving skills

People management skills

Education

Bachelor’s Degree

Minimum 14 years experience in pharmaceutical industry

10 years clinical trial management experience

Tools

Microsoft Suite (Word, Excel, PowerPoint, Outlook)

Clinical trial related software (e.g., eCRFs, IRT, CTMS)

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Clinical Management in Rockville, MD. This role involves the operational strategy and management of clinical programs, ensuring compliance with regulations.

The ideal candidate will have a Bachelor’s Degree and a minimum of 14 years in the pharmaceutical industry, with at least 10 years in clinical trial management. Key responsibilities include managing teams and overseeing clinical trial operations, with a focus on data integrity and regulatory compliance.

Comprehensive benefits are offered, including medical, dental, vision, and generous leave policies.