Clinical Research Medical Director - Endocrinology

September 17

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Amgen

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Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• 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. • 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 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. • 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.

Requirements

• MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research. • 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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions. • Group medical, dental and vision coverage. • Life and disability insurance. • 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.