Clinical Development Director – Oncology

🕒 Maio 16

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $274.788 - $371.773 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Support Clinical Development in Prostate cancer • Supporting the development, execution and communication of the global scientific/medical evidence plan • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program • Supporting the development of key scientific external relationships with opinion leaders • Participating and providing clinical input into safety and regulatory interactions • Provide clinical/scientific input during the development and execution of clinical trials • Interpret clinical trial data • Participate in safety assessments • Participate in interactions with regulatory agencies • Author CSRs, 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 Leader • Identify new clinical research opportunities • Support in-licensing and out-licensing activities and partner relationships • Support product lifecycle management for new indications as directed by Global Development Leader • Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs, Materials to be used by the Commercial Organization

🎯 Requisitos

• MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research • 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer) • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale • Familiarity with concepts of clinical research and clinical trial design, including biostatistics • Sound scientific and clinical judgment • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication • Demonstrated ability as a medical expert in a complex matrix environment • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

🏖️ Benefícios

• A 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 • Flexible work models where possible