Early-Phase Clinical Development Lead

Amgen; United States; Remote; USD 275,000 - 372,000; Full time

Job summary

Amgen is seeking a Clinical Development Director to lead early phase development from first-in-human studies through proof-of-concept. You will design and deliver early clinical trials, work with cross-functional teams, and support protocol and IND development, study start-up, data review, monitoring and analysis.

The role requires an MD or DO with at least 2 years in clinical development and a track record in leading complex trials within a matrix environment.

Qualifications

• MD or DO degree from an accredited medical school.
• 2 years of industry or academic/basic sciences/clinical development experience.
• Strong collaboration and leadership in a matrix environment.
• Excellent interpersonal and presentation skills; able to communicate with internal and external partners.

Responsibilities

• Lead the design and execution of early clinical development strategies for Inflammation, General Medicine or Rare Disease candidates.
• Prepare clinical development plans, study protocols, informed consents, and regulatory submissions.
• Review safety, efficacy, pharmacodynamics and pharmacokinetic data from trials.
• Collaborate with internal teams and external experts to guide drug development decisions.
• Support external licensing or partnering opportunities in cardiometabolic/general medicine areas.

Skills

Leadership qualities

Interpersonal skills

Presentation skills

Clinical trial design

Regulatory understanding

Education

MD/DO degree

Job description

Amgen is seeking a Clinical Development Director to lead early phase development from first-in-human studies through proof-of-concept. You will design and deliver early clinical trials, work with cross-functional teams, and support protocol and IND development, study start-up, data review, monitoring and analysis.

The role requires an MD or DO with at least 2 years in clinical development and a track record in leading complex trials within a matrix environment.