Senior Medical Director, Early Oncology Development

BioSpace; Washington (District of Columbia); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plan

Flexible work options

Job summary

Amgen is seeking a Clinical Development Director in Washington, DC to lead early phase oncology development, from first-in-human studies through proof-of-concept. You will collaborate on trial design, protocol development, data review, and regulatory interactions to advance promising cancer therapies.

You will work with cross-functional teams across Research, Regulatory, Safety and Commercial groups, contributing leadership and strategic vision in a matrix environment to meet tight timelines and

Qualifications

• MD/DO degree with Oncology specialization.
• 2 years of industry or academic clinical research/drug development experience.
• Board certified or eligible in Oncology.

Responsibilities

• Contribute to design and implementation of early clinical development strategy for oncology candidates.
• Prepare clinical development plans, protocols, informed consents, Investigators’ Brochures, ethics committee and regulatory submissions.
• Review and evaluate clinical study safety, efficacy, pharmacodynamics and pharmacokinetic data.
• Contribute to strategy and use of biomarkers to facilitate drug development.
• Collaborate with colleagues across departments and with external experts.

Skills

Leadership

Clinical trial design

Cross-functional collaboration

Regulatory submissions

Education

MD/DO

Oncology residency

Board certification (Oncology)

Job description

Amgen is seeking a Clinical Development Director in Washington, DC to lead early phase oncology development, from first-in-human studies through proof-of-concept. You will collaborate on trial design, protocol development, data review, and regulatory interactions to advance promising cancer therapies.

You will work with cross-functional teams across Research, Regulatory, Safety and Commercial groups, contributing leadership and strategic vision in a matrix environment to meet tight timelines and