Global Oncology Clinical Development Leader

Johnson & Johnson Co.; Cambridge (MA); Hybrid; USD 232,000 - 401,000; Full time

Benefits offered by this job

Long-term incentive program

401(k) plan with company match

Paid time off and holidays

Job summary

Johnson & Johnson seeks an experienced oncology leader to drive strategy and execution across the INTO Early Development Portfolio and oversee global regulatory submissions. You will partner with clinical leaders, scientists and stakeholders to advance trials, balance budget and timelines, and interact with regulators and key opinion leaders.

You will mentor teams, influence cross-functional partners, and contribute to NDA/MAA preparations while championing Cullman Credo values and

Qualifications

• MD/DO or equivalent is required; an advanced degree (MS or PhD) is a plus.
• Minimum 8–10 years of oncology experience in pharma or academia.
• Board certified or eligible medical oncologist preferred; solid tumor oncology experience valued.

Responsibilities

• Define vision, strategy and accountability across the INTO Early Development Portfolio.
• Support clinical leaders and scientists with strategy, plans, trial cost and safety surveillance; lead regulatory submission plans.
• Collaborate with Data Management, Biostatistics, Regulatory, Engineering, Global Development, Quality and GMS for integrated execution.
• Ensure portfolio stays on time and on budget through life cycle phases including study start-up and data review.
• Evaluate scientific information to identify new research opportunities and support the INTO Discovery Forum.
• Oversee NDA/MAA development and responses to Health Authority questions and presentations.
• May review medical publications emerging from trials.
• Foster relationships with global Key Opinion Leaders and external stakeholders.
• Interact with medical consultants for IDMC/Investigator meetings and Advisory Boards.

Skills

Oncology leadership

Executive communication

Cross-functional collaboration

Regulatory strategy

Clinical trial oversight

IND/NDA submissions

Mentoring/people management

Strategic planning

Global/hs regulatory liaison

Study start-up leadership

Education

MD, DO or equivalent

Advanced degree (MS/PhD) a plus

Job description

Johnson & Johnson seeks an experienced oncology leader to drive strategy and execution across the INTO Early Development Portfolio and oversee global regulatory submissions. You will partner with clinical leaders, scientists and stakeholders to advance trials, balance budget and timelines, and interact with regulators and key opinion leaders.

You will mentor teams, influence cross-functional partners, and contribute to NDA/MAA preparations while championing Cullman Credo values and