Clinical Research Medical Director – Oncology (Kyprolis)
Job ID: R-75848
Location: Thousand Oaks, CA, US 91360
Amgen's Oncology Global Development team is hiring a Clinical Research Medical Director in Thousand Oaks, CA.
This role is responsible for:
- 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 GDL
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
MD or DO degree from an accredited medical school
2 years of clinical research experience and/or basic science research
- MD plus accredited residency in Hematology or Oncology, board certified or equivalent
- 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
- 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
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.