Digital Health Executive Director

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-30448
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Amgen is searching for a Digital Health Executive Director within our new Innovation group. This will be based either at our headquarters in Thousand Oaks, CA or in our Washington D.C. offices and will report to the Executive Director, Innovation.
The Digital Health Executive Director will draw on his or her substantial experience in the regulation of drugs, biologics, and devices, as well as a prior exposure to digital health technologies, to identify, evaluate, and incorporate into Amgen's medicines emerging digital health technologies such as sensors, apps, data analytics, and connected services. Many of these health technologies are not yet covered by detailed regulatory guidance. In partnership with Amgen's regulatory, legal and privacy departments, this Executive Director will be exercising judgment on the feasibility and suitability of such emerging digital health technologies in the absence of detailed regulation or precedence.
This is an executive leadership role with single-point accountability and responsibility for execution of new Amgen health technologies into the regulated healthcare markets. The successful candidate will oversee both pilot and full-scale implementation of novel digital health technologies in the U.S., EU and JAPAC regions. She/he will recruit, retain and contract with the necessary human capital to move a portfolio of projects from proof of concept to approved technology, digital device or combination product.
Many health technologies do not yet enjoy detailed or regionally-consistent regulatory guidance. Moreover, that which is technologically possible may not in all cases be appropriate in healthcare or best serve the interests of patients. Successful and lasting implementation of health technologies will require expert judgement and deep experience with regulatory engagements around the world. Additionally, teams developing novel health technologies will necessarily have diverse backgrounds, academic credentials and work experience. The Digital Health Executive Director must mentor staff in order to imbue a culture of patient-centricity, respect for data privacy and fulsome understanding of regulatory feasibility. In addition she/he must develop program risk identification and mitigation measures that underscore Amgen's judgement and rationale in fielding health technologies in the absence of detailed regulation.
The Digital Health Executive Director will take projects forward from various levels of maturity following a governance decision to proceed to pilot. She/he must identify the best locations and teams for implementation and will prepare clear summaries and presentations of progress to plan for senior management review. The role may also include the support of transactional and licensing activities.
This is a technology development and implementation role and neither a legal nor a compliance role. The Digital Health Executive Director will be accountable for development of strong working relationships with Amgen's Law, Compliance and Privacy departments, data-driven decision making and establishment of best-practice based processes.
Basic Qualifications
Juris Doctorate degree & 15 years of Regulatory and/or Legal experience OR
Master's degree & 15 years of Regulatory and/or Legal experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
Juris Doctorate or Master's in Public Health Degree, with 10 or more years of experience in regulatory law or regulation (FDA, EMA, etc), and robust working knowledge of biotechnology, drug and device statute and guidance.
Partner-level, client-facing legal engagement experience in service of biotechnology or medical device industry.
1 or more years of industry experience in digital and health technologies including mobile technology, data analytics, machine learning, customer experience, consumer electronics and wearable sensors.
Experience in business and drug development activities with strong technical regulatory law experience.
Experience in risk-mitigation for development of new medical or consumer electronics technologies.
Strong scientific, organizational, communication, and project management skills and ability to manage multiple projects simultaneously, with a record of key accomplishments.
Excellent presentation skills.
Effective communication skills pertaining to scientific and business development.
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.

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