Oncology Clinical Development Director

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 199,000 - 344,000; Full time

Benefits offered by this job

401(k) plan

Pension

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson Innovative Medicine is actively advancing oncology medicines, engaging in discovery and development from lab to patient. This role leads a team of clinicians and scientists, driving study design, monitoring, and regulatory submissions across late-stage development.

The ideal candidate holds an MD with uro-oncology/oncology expertise and 3+ years in clinical research, able to navigate cross-functional teams and global health- authority processes while delivering high-quality

Qualifications

• Advanced degree in Medicine (MD or equivalent) with oncology/urology specialization.
• Minimum 3+ years in a relevant uro-oncology/clinical research position.
• Strong communication, writing and presentation skills; experience in a matrix, cross-functional environment.

Responsibilities

• Leads project scientists, ensuring training, mentoring and supervision across studies.
• Collaborates with Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS for flawless execution and oversight of protocols.
• Supports clinical studies with medical monitoring, timely responses to site issues, and SAE reviews.
• Co-develops high-quality study protocols with standardized processes across studies.
• Oversees NDA/MAA development and assists Health Authority interactions; supports publication activities.
• Interacts with investigators and key opinion leaders as appropriate; oversees CRO/vendor performance in startup and conduct.

Skills

Clinical Research

Regulatory Affairs Management

Clinical Trials

Data Management and Informatics

Education

Advanced Degree in Medicine (MD)

Job description

Johnson & Johnson Innovative Medicine is actively advancing oncology medicines, engaging in discovery and development from lab to patient. This role leads a team of clinicians and scientists, driving study design, monitoring, and regulatory submissions across late-stage development.

The ideal candidate holds an MD with uro-oncology/oncology expertise and 3+ years in clinical research, able to navigate cross-functional teams and global health- authority processes while delivering high-quality