Amgen Medical Sciences Director in South San Francisco, California

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.

Integral to the ongoing success of Amgen's comprehensive biomarker programs, the Medical Sciences In Vitro Diagnostics (IVD) Group is responsible for the transition of exploratory biomarkers to marketed IVDs, working with other functions within Amgen to identify the appropriate partner for diagnostic test development. The Director uses a breadth of communication expertise across a broad range of stakeholders, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.

Responsibilities:

Managing the In Vitro Diagnostics team as part of the Clinical Biomarker & Diagnostics function

Overseeing IVD technical development activities

Formulating and implementing companion diagnostic development strategies through integration of functional stakeholder input

Developing project plans including resource identification, budget, facility and regulatory requirements to meet project goals

Leading cross-functional teams required to successfully manage and execute external diagnostic development partnerships through regulatory approval in multiple jurisdictions and the test's life cycle as companions to Amgen's therapeutics

Driving external interactions with the Dx community, advocacy and policy groups

Basic Qualifications:

Doctorate degree and 4 years of pharmaceutical and/or diagnostic experience

OR

Master's degree and 8 years of pharmaceutical and/or diagnostic experience

OR

Bachelor's degree and 10 years of pharmaceutical and/or diagnostic experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

Experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets

Knowledge and experience in clinical trial design

Experience integrating data from multiple sources and identifying critical process variables.

Experience establishing and reviewing complex plans for multiple projects or activities. This includes planning resource allocation and distribution and identifying contingency plans.

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.