Medical Sciences Director, Obesity/Cardiovascular - US, Remote

Career Category

Job Description

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.

Medical Sciences Director, Obesity/Cardiovascular - US, Remote

What you will do

Let’s do this. Let’s change the world. Amgen is advancing our Obesity and Cardiometabolic pipeline. We seek collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.

To support that effort, the Obesity and Cardiometabolic Late Development Group is looking for a Medical Sciences Director.

In this vital role, the Medical Sciences Director will contribute to late phase clinical development of maridebart cafraglutide (AMG 133) in obesity and cardiovascular diseases. They will collaborate on teams to define, design, and deliver late phase clinical results. In this vital role, the Medical Director will provide expertise in translating clinical development strategy into clinical trial protocols, ensuring clinical trial data integrity, and contributing to interpretation of results. In this role, you will report directly to the Global Development Lead for cardiovascular indications.

• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
• Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results.
• Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
• Support medical monitor in clinical trials and assist in resolving issues that may arise
• Conduct thorough data quality assessments to maintain high standards of data accuracy and integrity throughout the trial lifecycle
• Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
• Provide guidance and assistance in the identification and management of external collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects

What we expect of you

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.

Basic Qualifications:

Doctorate degree and 4 life sciences/healthcare experience

OR

Master’s degree and 7 life sciences/healthcare experience

OR

Bachelor’s degree and 9 years life sciences/healthcare experience

Preferred Qualifications:

• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven track record of clinical trial process improvement
• Industry or academic experience in late-phase drug development, preferably in a cardiovascular or cardiometabolic therapeutic area
• Strong communication & presentation skills to clearly communicate scientific concepts/data to leadership committees both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
• Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
• Serving as a contributing author to scientific publications and data presentations at scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools

<