Amgen Clinical Research Medical Director - Inflammation in Thousand Oaks, California

The Bone, Nephrology and Inflammation TA is seeking a Clinical Research Medical Team member for:

Supporting the development, execution and communication of the global scientific/medical evidence plan in inflammation pipeline

Experience of cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the clinical development programs

Experience in regulatory interactions and clinical input into safety

Supporting the development of key scientific external relationships with opinion leaders

Key Activities

Provide clinical/scientific input during the clinical development plans and oversight into execution of clinical trials

Interpret clinical trial data and participate in safety assessments

Participate in interactions with regulatory agencies and internal governance meetings

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 into appropriate documents

#LI-POST

MD01

Basic Qualifications

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications

MD plus accredited residency in relevant sub-specialty (pulmonary, rheumatology or internal medicine), board certified or equivalent

3+ years of clinical research experience including involvement with clinical protocols and participating in clinical trials

4+ years of clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in the rheumatology, pulmonary or inflammation

Knowledge

Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes

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 to broader teams and management

Demonstrated ability as a medical expert and lead teams in a complex matrix environment

History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

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.

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.