Clinical Research Medical Director, Cardiometabolic

Overview

Join Amgen s Mission of Serving Patients. At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas — Oncology, Inflammation, General Medicine, and Rare Disease — we reach millions of patients each year.

As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

Clinical Research Medical Director, Cardiometabolic

Lets do this. Lets change the world. In this vital role you will support the development, execution and communication of the global scientific/medical evidence plan. Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program. Support the development of key scientific external relationships with opinion leaders. Participate and provide clinical input into safety and regulatory interactions.

• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author CSRs, publications and regulatory submissions
• Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by GDL
• Identify new clinical research opportunities
• Support in-licensing and out-licensing activities and partner relationships
• Support product lifecycle management for new indications as directed by Global Development Leader
• Provide clinical content input to: regulatory interactions and documents, safety interactions and documents, materials to be used in Scientific Affairs, and materials to be used by the Commercial Organization

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

• Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Five or more years of clinical research experience and/or basic science research combined with clinical instructing and patient care activities
• Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in relevant sub-specialty
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
• Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Leadership experience/potential as a medical expert in a complex matrix environment
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we…