Clinical Research Medical Director

4 weeks ago

Washington, Washington, D.C., United States Amgen Full time

Job Summary

Clinical Research Medical Director - Obesity/ Cardiovascular Expert

Amgen is seeking a highly experienced Clinical Research Medical Director to lead our Obesity and Cardiovascular programs. As a key member of our global clinical development team, you will be responsible for providing clinical/scientific knowledge into the development, delivery, and communication of the global scientific/medical evidence plan for the assigned indication(s).

Key Responsibilities

  • Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan for Obesity and Cardiovascular programs.
  • 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 presentations 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.
  • Interact with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc.

Requirements

  • MD or DO degree from an accredited medical school.
  • 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 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.

About Amgen

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.

Equal Opportunity Employer

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.

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