Clinical Research Medical Director Endocrinology/Obesity , US - Remote

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

What you will do

The Cardiovascular/Metabolic Therapeutic Area is seeking a Clinical Research Medical Director to play a leadership role on one or more studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. The position is located in Thousand Oaks, California, but depending on the situation a remote work arrangement will be considered. The role will report directly to the Global Development Lead for the AMG 133 program.

Responsibilities

• Provide clinical/scientific knowledge into the development, design, execution and communication of the global evidence generation plan for the maridebart cafraglutide (AMG 133) phase 3 program.
• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Participate and provide clinical input into safety and regulatory interactions
• Interpret and communicate clinical trial data
• Author clinical study reports, publications and regulatory submissions
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead
• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
• Contribute to TPP (target product profile) and Global Product Safety (GPS) development
• Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG)
• Responsible for interfacing with TA leadership and extended team to develop options
• Responsible for interfacing with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options.

What we expect of you

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

Basic Qualifications

MD or DO degree from an accredited medical school

AND

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

Preferred Qualifications

• Five (5) years of experience in late clinical development as part of a pharmaceutical organization.
• Five (5) years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Strong and versatile clinical development experience in endocrinology or any of sub-areas, 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $256,334. - $318,868.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now for a career that defies imagination.

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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