Clinical Development Director - Oncology
Career Category
Clinical Job Description
Join Amgen ’s Mission of Serving Patients
At Amgen , if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Clinical Development Director - Oncology
What you will do
Let’s do this. Let’s change the world. In this vital role you will support Clinical Development in Prostate cancer.
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Supporting the development, execution and communication of the global scientific/medical evidence plan
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Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
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Supporting the development of key scientific external relationships with opinion leaders
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Participating and providing clinical input into safety and regulatory interactions
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Provide clinical/scientific input during the development and execution of clinical trials
- Interpret clinical trial data
- Participate in safety assessments
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Participate in interactions with regulatory agencies
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Author CSRs, publications and regulatory submissions
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Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
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Identify new clinical research opportunities
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Support in-licensing and out-licensing activities and partner relationships
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Support product lifecycle management for new indications as directed by Global Development Leader
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Provide clinical content input to:
- Regulatory interactions and documents
- Safety interactions and documents
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Materials to be used in Scientific Affairs
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Materials to be used by the Commercial Organization
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The clinical development professional we seek has these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
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2 years of clinical research experience and/or basic science research
Preferred Qualifications:
·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 su