Amgen Global Development Leader, Clinical Development, Oncology in Thousand Oaks, California
The Global Clinical Development therapeutic area is looking for a strong leader in Hematology/Oncology. This Medical Director, Global Development Leader, will lead phase II-III clinical development of oncology compounds.
They define, design, and execute clinical development as a strategy for drug development. They typically serve as project leaders for one or more of Amgen's Product Strategy Teams through their role as a Clinical Research Medical Director. These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
This role will include the following responsibilities:
Support the development and execution for clinical trials and be the medical science expert in resolving significant issues that may affect the studies.
Provide the strategy and execution of communication, presenting information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.
Ensure clinical approaches to operational issues and approve monitoring and safety-reporting resource plans.
Author CSRs, publications and regulatory submissions.
Support the development and execution of the trial portfolio including the identification and management of oncology phase 2-3 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.
Ensure appropriate programs within training, recruitment, and development requirements for matrix team resources
Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
Develop and interface with industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings and external committee meetings
Be the primary Medical Sciences contact for scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing early and later clinical development.
Develop a strategy for product growth by evaluating and identifying external opportunities for partnering or licensing new oncology assets
Support the Global Brand Team in the brand planning process to ensure alignment between medical and brand activities, and help providing interpretation of clinical study data
2 or more years of Clinical Trial and/or Research Experience
Subspecialty board eligibility/certification in Oncology and/or Hematology
Strong basic science or clinical research background in academia or industry
Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
Effective presentation and communication abilities (both written and oral)
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
A record of high quality peer-reviewed publications
Experience functioning as a medical expert in a complex matrixed environment
Previous experience in late stage oncology clinical trials and regulatory filings
Knowledge of GCP, EMA, and FDA policies
Expertise in authoring clinical sections of CTA or INDs
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.