Clinical Development Director, Obesity & Cardiovascular

Regulatory Jobs; United States; On-site; USD 275,000 - 372,000; Full time

Benefits offered by this job

Flexible work models where possible

Job summary

Amgen is seeking a Clinical Development Director, Obesity/Cardiovascular, to lead late-stage studies within the obesity/ cardiometabolic program and shape the global evidence generation plan. You will report to the Global Development Lead for cardiovascular indications and work across functions to advance study concepts and regulatory submissions.

The role requires an MD/DO with at least 3 years of clinical research experience, strong GCP knowledge, and demonstrated leadership in a complex

Qualifications

• MD or DO degree from an accredited medical school.
• 3 years of clinical research experience.
• Three or more years of clinical research experience in biopharmaceutical industry (biotech/pharma/CRO).
• Knowledge of pharmaceutical product development, lifecycle, and commercialization processes.
• Experience drafting regulatory submissions and safety reviews.
• Strong communication & presentation skills; leadership in a matrix environment.

Responsibilities

• Provide clinical/scientific input into development plans and evidence generation for obesity/cardiometabolic programs.
• Collaborate cross-functionally to translate strategy into study concepts, protocols and related documents.
• Provide clinical input into trial design, data review, and regulatory interactions.
• Serve as medical monitor for ongoing trials and review safety data.
• Author clinical study reports, publications and regulatory submissions.
• Engage with key opinion leaders and present at advisory boards and meetings.

Skills

Clinical research experience

Communication & presentation

Interpersonal & problem-solving

GCP & regulatory knowledge

Leadership in matrix environment

Medical expertise

Education

MD or DO

Job description

Amgen is seeking a Clinical Development Director, Obesity/Cardiovascular, to lead late-stage studies within the obesity/ cardiometabolic program and shape the global evidence generation plan. You will report to the Global Development Lead for cardiovascular indications and work across functions to advance study concepts and regulatory submissions.

The role requires an MD/DO with at least 3 years of clinical research experience, strong GCP knowledge, and demonstrated leadership in a complex