Clinical Development Director, Early Development – Cardiometabolic/General Medicine

About the role

Join Amgen’s mission of serving patients. In this vital role, you will lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. You will collaborate on teams to support the design and delivery of early phase clinical trials, contributing to protocol development, study start-up, data review, monitoring, and analysis activities.

Responsibilities

• Contribute to the design and implementation of the early clinical development strategy for cardiometabolic/general medicine therapeutic candidates.
• Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions.
• Review and evaluate clinical study safety, efficacy, pharmacodynamic, and pharmacokinetic data.
• Contribute to the strategy and use of clinical biomarkers to facilitate drug development.
• Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety, and Commercial colleagues.
• Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas.
• Collaborate with external experts to provide biomedical expertise and strategic guidance to cardiometabolic/general medicine Early Development teams.

Qualifications

Basic Qualifications

• MD or DO degree from an accredited medical school.
• 2 years of industry or academic/basic sciences/clinical research experience.

Preferred Qualifications

• Board certification or eligible (Internal Medicine, Cardiology, or Endocrinology).
• Residency training in Internal Medicine and relevant subspecialty.
• Understanding of cardiometabolic and general medicine pathophysiology.
• Experience in basic research and/or clinical trial methodology.
• 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials.
• Experience collaborating with pharmaceutical sponsors.
• Experience in designing, monitoring, and implementing clinical trials and interpreting trial results.
• Demonstrated leadership qualities; capable of conducting studies as part of a team.
• Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines.
• Publication track record.
• Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators.

Benefits

From our competitive benefits to our collaborative culture, we support your professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.