Clinical Development Medical Director, Obesity and Related Conditions

Amgen•Thousand Oaks, CA

4d•$274,789 - $371,773

About The Position

Amgen’s Obesity Therapeutic Area is seeking a Clinical Development Medical Director to contribute to one or more late-phase studies in the maridebart cafraglutide (AMG 133) global development program for obesity and related metabolic diseases. The role provides clinical and scientific expertise for development, design, delivery, and communication of the global evidence-generation plan for the Phase 3 program. The position reports directly to the Global Development Lead for cardiovascular indications.

Requirements

MD or DO degree from an accredited medical school.
At least 3 years of clinical research experience.

Nice To Haves

At least 3 years of clinical research experience in the biopharmaceutical industry, ideally in late-phase development in a cardiometabolic or adjacent therapeutic area.
At least 5 years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities.
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
Experience developing study concepts and clinical trial designs with cross-functional input, including biostatistics, observational research, and patient-reported outcomes, for Phase 2 and/or 3 trials in obesity, diabetes, or cardiovascular indications.
Experience with clinical trial medical data review, medical monitoring and/or safety review and interpretation, including electronic aggregate data review tools.
Experience drafting high-level submission documents and authoring clinical regulatory responses for health regulatory interactions.
Strong written and oral communication and presentation skills for clearly communicating scientific concepts.
Strong interpersonal skills and problem-solving abilities, superior judgment, and a balanced, realistic understanding of issues and resolution paths.
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
Leadership experience or potential as a medical expert in a complex matrix environment.

Responsibilities

Provide clinical and scientific expertise for development, design, delivery, and communication of the global evidence-generation plan for maridebart cafraglutide (AMG 133) Phase 3 programs.
Work cross-functionally to translate clinical strategy into study concept documents, protocols, and related documents.
Provide clinical input into and support implementation and delivery of clinical trials, including clinical data review and interpretation of results.
Serve as medical monitor for ongoing clinical trials.
Review and analyze clinical trial data for accuracy, completeness, and adherence to protocol and regulatory requirements.
Participate in safety and regulatory interactions and provide clinical input.
Author clinical study reports, publications, and regulatory submissions.
Develop relationships with key opinion leaders and give scientific presentations at advisory boards, key scientific meetings, and external committee meetings as delegated by the Global Development Lead.