Clinical Research Medical Director - CKD, US - Remote

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Requirements:

• MD or DO degree from an accredited medical school
• 2 years of clinical research experience and/or basic science research
• 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 nephrology, outcomes studies 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 cardiovascular disease or heart failure
• 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

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.