HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Clinical Research Medical Director, Endocrinology, US - RemoteLiveWhat you will doLet’s do this. Let’s change the world.The Obesity 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. In this vital role, you will report directly to the Global Development Lead for the assigned indication.
Provide clinical/scientific knowledge into the development, design, delivery and communcation 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), Obesity Leadership Team (OLT)
Interact with TA leadership and extended team to develop options
Interact with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options.
WinWhat we expect of youWe 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 schoolAND2 years of clinical research experience and/or basic science researchPreferred Qualifications:
Type 2 Diabetes experience
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 teaching 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
ThriveWhat you can expect of usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.