Clinical Research Medical Director - Biosimilars
Amgen is seeking a Clinical Research Medical Director (CRMD) - Biosimilars at its main headquarters in Thousand Oaks, CA to join the Biosimilars - Development organization. The CRMD is a medical expert providing critical clinical and scientific input into the clinical strategy and oversight of the clinical studies for the development of biosimilars. Responsibilities include protocol development, study oversight and monitoring, data interpretation and communication of results.
The Clinical Research Medical Director will report to the Executive Medical Director and will participate and provide clinical input into safety and regulatory interaction. The CRMD will support the development of key scientific external relationships with opinion leaders.
Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate comparability to the originator product.
Key Activities for the Clinical Research Medical Director (CRMD) include:
- 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 regulatory submissions and publications
- Develop key opinion leaders and make scientific presentations
- Support in-licensing and partner relationships
- Support product lifecycle management
- Supporting the development, execution and communication of the global clinical plan
- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
- MD with clinical experience in Rheumatology or Oncology
- Two (2) or more years of clinical research experience in biotechnology/pharmaceutical industry or CRO company
- MD plus accredited residency in Rheumatology or Oncology, board certified or equivalent
- Five (5) or more years of clinical research experience in biotech/pharma/CRO company and basic science research combined with clinical teaching or patient care activities
- 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
- Experience in all phases of clinical research (Phase 1-4)
- Experience interacting with FDA and international regulatory agencies
- Ability to multi-task, overseeing different activities and different projects at the same time
- Personal responsibility for delivery of quality output according to timelines
- Flexibility, and ability to drive change and simplify processes
- Team work and cross-functional alliance, across Amgen and with vendors
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.