Clinical Research Medical Director - Obesity

November 26

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Amgen

WebsiteLinkedInAll Job Openings

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

Description

• 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. • Provide clinical/scientific input during the development and execution clinical trials. • Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols). • Interpret clinical trial data and participate in safety assessments. • Review and provide clinical scientific input to safety narratives. • Initiate database analyses to support commercial/clinical objectives. • Contribute to the preparation of clinical study reports and regulatory submissions. • Participate in interactions with regulatory agencies. • Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings and identify new clinical research opportunities.

Requirements

• Doctorate degree and 2 years of experience in obesity, diabetes, MASH or metabolic diseases • Accredited residency/fellowship in hepatology or endocrinology, board certified or equivalent • 2 years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities • Prior research in MASH, obesity, diabetes, or metabolic diseases • An understanding of the scientific method and clinical applications based medical, scientific and practical rationale • Familiarity with concepts of clinical research and clinical trial design including biostatistics • Familiarity with regulatory agency organization, guidelines, and practices • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication • History of solving problems while exhibiting superior judgment and balanced, realistic understanding of issues.

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, • 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