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For your reference, we have included the original job posting below.
Clinical Research Medical Director - Biosimilars
Job Number:
41708840
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Clerical & Administrative Research
Clinical Research Medical Director - Biosimilars
The Clinical Research Medical Director (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. Success includes excellent cross-functional coordination within Amgen and with partners. Responsibilities include protocol development, study oversight and monitoring, data interpretation and communication of results.
The Clinical Research Medical Director (Biosimilars) is responsible for: • 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 • Participating and providing clinical input into safety and regulatory interactions • Supporting the development of key scientific external relationships with opinion leaders
This role will be located at Amgen's Thousand Oaks headquarters.
Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research
Preferred Qualifications • 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 • Experience in all phases of clinical research (Phase 1-4) • Experience interacting with FDA and international regulatory agencies • 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
• 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
