Director, Early-Phase Clinical Development

Amgen Inc. (IR); Northern (KY); Hybrid; USD 275,000 - 372,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible

Job summary

Amgen Inc. (IR) seeks a Clinical Development Director to lead early phase studies from first-in-human through proof-of-concept.

You will design and support INDs, study start-up, data review, and safety analyses while collaborating with Precision Medicine, Research, and Regulatory teams. Ideal candidates will have MD/DO with 3+ years in pharma/academia, clinical trial methodology experience, and strong leadership, communication, and publication credentials.

Qualifications

• MD or DO with 2 years of industry or academic clinical development experience.
• Board certification or eligible (Internal Medicine or subspecialty) preferred.
• Residency in Internal Medicine/subspecialty preferred.
• Understanding of pathophysiology in inflammatory/general medicine/rare diseases.
• Experience in basic research and/or clinical trial methodology.
• 3+ years of drug development experience in pharma/academia, ideally in early stage trials.
• Experience collaborating with sponsors and cross-functional teams.
• Experience designing, monitoring and interpreting clinical trials; strong leadership in matrix environments.
• Publication track record and excellent communication with stakeholders.

Responsibilities

• Lead early phase clinical development of compounds from FIH to proof-of-concept.
• Collaborate on design and delivery of early phase trials and protocol/IND development.
• Support study start-up, data review, monitoring and analysis activities.
• Contribute to clinical development plans and regulatory submissions.
• Collaborate with Internal Medicine, Rare Disease, and other teams; evaluate external licensing opportunities.
• Provide biomedical guidance to Early Development teams and external experts.

Skills

Leadership qualities

Interpersonal skills

Presentation skills

Education

MD/DO degree

Job description

Amgen Inc. (IR) seeks a Clinical Development Director to lead early phase studies from first-in-human through proof-of-concept.

You will design and support INDs, study start-up, data review, and safety analyses while collaborating with Precision Medicine, Research, and Regulatory teams. Ideal candidates will have MD/DO with 3+ years in pharma/academia, clinical trial methodology experience, and strong leadership, communication, and publication credentials.