Clinical Research Medical Director - Oncology

📋 Description

• • Amgen is seeking a highly skilled and experienced Clinical Research Medical Director to join our dynamic team, focusing on the critical area of Prostate cancer within our Oncology therapeutic area.
• • This pivotal role is instrumental in supporting the development, execution, and communication of the global scientific and medical evidence plan for our investigational and approved therapies.
• • You will be a key contributor to integrating broad medical, scientific, and commercial insights into our development programs through robust cross-functional and global collaborations.
• • A significant aspect of this role involves cultivating and maintaining strong external scientific relationships with Key Opinion Leaders (KOLs) in the field of oncology, particularly in prostate cancer.
• • You will actively participate in and provide crucial clinical input during safety and regulatory interactions, ensuring compliance and strategic alignment.
• • The position requires providing expert clinical and scientific input throughout the entire lifecycle of clinical trials, from design to execution.
• • A core responsibility will be the meticulous interpretation of clinical trial data, drawing meaningful conclusions to inform future research and development strategies.
• • You will play an active role in safety assessments, contributing to the ongoing evaluation of the benefit-risk profile of our medicines.
• • Engagement with regulatory agencies, providing clinical and scientific expertise, will be a regular part of your duties.
• • You will be responsible for authoring Clinical Study Reports (CSRs), contributing to scientific publications, and preparing regulatory submissions.
• • Developing relationships with Key Opinion Leaders (KOLs) and presenting scientific data at advisory boards, key scientific meetings, and external committee meetings will be delegated by the Global Development Leader.
• • You will be tasked with identifying new clinical research opportunities that align with Amgen's strategic objectives and patient needs.
• • Support for in-licensing and out-licensing activities, as well as managing partner relationships from a clinical perspective, will be required.
• • You will contribute to product lifecycle management, including the development of new indications, as directed by the Global Development Leader.
• • Providing essential clinical content input for regulatory interactions and documents is a key function.
• • Similarly, you will provide clinical content input for safety interactions and documents, ensuring comprehensive and accurate reporting.
• • You will contribute clinical content to materials intended for use by the Scientific Affairs department.
• • Furthermore, you will provide clinical content input for materials developed for the Commercial Organization, ensuring scientific accuracy and compliance.
• • This role offers a unique opportunity to make a profound impact on the lives of patients battling serious illnesses by advancing innovative cancer treatments.
• • You will be part of a science-based, collaborative, and innovative culture that is dedicated to serving patients.
• • The position requires a deep understanding of the scientific method and its clinical applications, grounded in medical, scientific, and practical rationale.
• • Familiarity with the principles of clinical research, clinical trial design, and biostatistics is essential.
• • You will leverage your sound scientific and clinical judgment to guide research efforts.
• • A thorough knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations, and applicable international regulatory requirements is expected.
• • The ability to effectively communicate complex medical and clinical concepts, both verbally and in writing, is critical for success in this role.
• • You will demonstrate your expertise as a medical professional within a complex matrix environment, collaborating effectively across diverse teams.
• • A proven history of problem-solving, exhibiting superior judgment, and maintaining a balanced, realistic understanding of issues will be highly valued.
• • This role is remote, offering flexibility while maintaining a significant impact on global clinical development strategies.