Global Development Lead - Inflammation

Employer
Amgen
Location
Thousand Oaks, California
Posted
Oct 17, 2018
Ref
R-64877
Required Education
Bachelors Degree
Position Type
Full time

The Bone, Nephrology and Inflammation Therapeutic Area is seeking a Clinical Research Medical Director, Global Development Leader for a global, high priority Phase 1b/2 inflammation program. The program is currently developing AMG 592, IL-2 mutein, in multiple autoimmune inflammatory conditions.

This position is located in Thousand Oaks, California and will have an opportunity to shape the growing Inflammation Therapeutic Area and will report directly to the Global Program Area Lead, Inflammation. Responsibilities include:

  • Serve as the clinical lead for Amgen and contribute to the product strategy for AMG 592
  • Develop and execute global clinical development strategy, and communication of the global scientific/medical evidence plan for multiple indications
  • Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies
  • Provide clinical content input to:
    • Regulatory interactions and documents
    • Safety interactions and documents
  • Seek global cross-functional collaborations to integrate broad medical, scientific, and commercial and payor input into the development program
  • Provide clinical input into safety and regulatory submissions/interactions and participate in regulatory interactions
  • Interpretation and communication of clinical trial data
  • Develop key external relationships to foster research and support clinical development activities; make scientific presentation at advisory boards, key scientific meetings and governance meetings as needed
  • Identify new clinical research opportunities and support product lifecycle management

Basic Qualifications

MD or DO degree from an accredited medical school

AND

5 years of clinical development experience in industry

Preferred Qualifications

* MD with strong (five years or more in biopharma) and versatile clinical development experience in inflammation such as RA, SLE, IBD: and accreditation in relevant sub-specialty (i.e. rheumatology, immunology, dermatology)

* Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes

* Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1,2 and/or 3 clinical trials in inflammation/immunology

* Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements

* Leadership and management experience/potential in leading evidence generation teams with ability as a medical expert in a complex matrix environment

* Prior regulatory experience with familiarity with 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

* Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path

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.