Senior Director, Early Oncology Clinical Development

Daiichi Sankyo

Basking Ridge (NJ)

On-site

USD 280,000 - 467,000

Full time

2 days ago

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Job summary

Daiichi Sankyo is seeking a Senior Director in Early Clinical Development to lead oncology trial programs from early development through regulatory strategy. You will supervise CRO activities, partner with Discovery and Translational Medicine, and shape development plans, biomarker strategies, and submissions.

You will engage with health authorities and senior management to align on program goals. The role requires extensive leadership of cross-functional teams across regions, with travel up to

Qualifications

MD or MD/PhD with relevant clinical and industry experience required in clinical oncology.
Postgraduate training in TA or related specialty required.

Responsibilities

Oversee CRO clinical monitoring activities and sponsor oversight; coordinate internal communications.
Monitor safety data and ensure global consistency of monitoring across projects.
Develop study strategy with function leaders; approve TM and biomarker strategy; attend regulatory meetings.
Plan and execute contingency plans; define priorities and execution plans across projects and regions.
Assess study design, statistics, and endpoints for registrational trials and early-stage work.
Lead external collaborations and advisory panels; maintain relationships with KEEs and CROs.

Skills

Oncology leadership

Clinical development

CRO management

Regulatory strategy

Cross-functional leadership

Education

MD or MD/PhD

Postgraduate TA training

Job description

You will engage with health authorities and senior management to align on program goals. The role requires extensive leadership of cross-functional teams across regions, with travel up to

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