Amgen
Biologics • Human therapeutics • Development of novel products
10,000+
💰 Post-IPO Debt on 2022-12
Clinical Research Medical Director - Obesity / Cardiovascular
October 1
Amgen
Biologics • Human therapeutics • Development of novel products
10,000+
💰 Post-IPO Debt on 2022-12
Description
• Serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the assigned indication(s) • 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), Therapeutic Area Governance (TAG)
Requirements
• MD or DO degree from an accredited medical school AND 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) preferred • Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities preferred • Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in relevant sub-specialty preferred • 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 • 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
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