Executive Medical Director/Global Development Leader (Inflammation)

Amgen is a biotechnology pioneer since 1980 and has grown to be one of the world's leading independent biotechnology companies, reaching millions of patients globally.

Amgen is developing a pipeline with breakaway potential and 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.

The Bone, Nephrology and Inflammation Therapeutic Area is seeking a Clinical Research Executive Medical Director, Global Development Leader for a global, high priority Phase 3 inflammation program. The program is currently developing tezepelumab, a TSLP inhibitor, in severe asthma and atopic dermatitis, in partnership with Astra Zeneca. Tezepelumab is a potential first-in-class medication blocking TSLP, an epithelial cytokine, critical in the initiation and persistence of airway/epithelial inflammation.

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 Tezepelumab and represent Amgen development in interactions with partner
• Develop the global development strategy, participate in execution and communication of the global scientific/medical evidence plan for multiple indications; in partnership and collaboration with AZ

• Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies
• Provide clinical content input to:

o Regulatory interactions and documents

o Safety interactions and documents

o Materials to be used in Scientific Affairs and Commercial Organization

• Seek global cross-functional collaborations to integrate broad medical, scientific, and commercial and payor input into the development program; in collaboration with partnership
• Provide clinical input into safety and regulatory submissions/interactions and participate in regulatory interactions as needed
• Participate in interpretation of clinical trial data and publication authorship, as appropriate
• 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 for new indications

BASIC QUALIFICATIONS

• MD or DO degree from an accredited medical school
• Five (5) or more years of clinical development experience in industry and academic clinical research AND
• Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

PREFERRED QUALIFICATIONS

• MD with strong (eight (8) or more years in biopharma) and versatile drug development experience in inflammation with accreditation in relevant sub-specialty (i.e. Pulmonology or Dermatology)
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical development, clinical operations, commercial and regulatory affairs
• Experience and knowledge in designing, conducting and analyzing Phase 1, 2 and/or 3 clinical trials in inflammation/immunology
• Prior experience of working in alliance/partnerships
• Strong leadership and management experience in leading evidence generation teams with ability as a medical expert in a complex matrix environment
• Prior regulatory and/or filing 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
• Experience solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path