Clinical Research Medical Director, T2D, US - Remote

Amgen Inc. (IR); United States; Remote; USD 261,000 - 330,000; Full time

Job summary

An established industry player is seeking a Clinical Research Medical Director to lead innovative studies in obesity and related metabolic diseases. This pivotal role involves collaborating with cross-functional teams to develop and communicate the global evidence generation plan. The ideal candidate will possess a strong background in clinical research, particularly in endocrinology or cardiology, and will be responsible for interpreting clinical trial data and authoring key documents. Join a forward-thinking organization that values collaboration and is committed to improving patient outcomes through groundbreaking research.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Stock-based long-term incentives

Award-winning time-off plans

Discretionary annual bonus program

Qualifications

• MD or DO degree from an accredited medical school required.
• 2+ years of clinical research experience is essential.

Responsibilities

• Lead clinical research studies within the obesity therapeutic area.
• Provide clinical/scientific knowledge for global evidence generation.

Skills

Clinical Research

Endocrinology

Cardiology

Clinical Trial Design

Regulatory Knowledge

Interpersonal Skills

Problem-solving

Education

MD or DO degree

Tools

Good Clinical Practices (GCP)

Job description

Clinical Research Medical Director, T2D, US - Remote

Clinical Research Medical Director, T2D, US - Remote

Apply remote type Remote locations United States - Remote time type Full time posted on Posted 3 Days Ago job requisition id R-209662

Career Category

Clinical Development

Job Description

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.

What you will do

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 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), 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.

What we expect of you

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:

• 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 2 and/or 3 clinical trials in diabetes or obesity.
• 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

The annual base salary range for this opportunity in the U.S. is $261,969. - $329,723.

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.

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.