Site Engagement Lead

Career Category

Clinical Development

**Job Description**:
HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Site Engagement Lead

LIVE

What you will do

In this vital role you will:
- Align and lead identification and strategic partnership with key sites to implement a collaborative initiative for clinical trial execution.- Set up strategic long-term operational partnerships with sites, provide local intelligence, and help in maintaining a consistent and coherent voice as part of Amgen’s overarching engagement strategy. Collaborate with other cross functional roles for ‘tailored’ global completion of study(ies).
- Be the first site-facing, cross-study decision-maker between Amgen and designated sites for the goals of establishing Amgen-Institutional operational working practices.
- Maintain country expertise, site knowledge to navigate with Amgen and sites with targeted and tailored communication.- Develop collaboration with Regional and/or Local Trial Manager (RCTM/LTM*) to ensure clear roles and responsibilities. Communicate cross-study lessons learned and maintain consistent working relationships with sites.- Share information and cross-study metrics to Key Stakeholders, e.g., DOM, DFM, CTOM, Study Managers etc.- Locally be accountable for targeted sites enablement of clinical studies.- Build and develop positive relationships with sites to engage with Amgen as Choice for clinical trial participation, to optimally advance site operational engagement and better understand site processes to enhance our clinical trial completion.- Set-up regular communication with sites to connect on all trials/all stages to identify trends and opportunities and enhance site’s experience with Amgen. On-site visits as appropriate (per site and situation).- Maintain quick and direct access to key sites’ leadership & operation teams, point of escalation for operational, cross-study potential barriers and operational issues.- Be the internal point of contact to navigate working with sites, and to help key sites work with Amgen.- Centralize and socialize site intelligence technology, such as working practices, operational documents, to enhance clinical trial efficiencies at site.- Participate in cross-functional task forces / process improvement groups.- Global Study Operations) quality management- Actively participate in role forums including local and global functional and cross-functional initiatives.- Participate in Functional Management Team (FMT) Meetings as required and applicable country-level project review meeting.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills.

Travels to sites are required (frequency to be defined).

BASIC QUALIFICATIONS

BA/BS/BSc on life sciences or medical sciences

OR

Research Nurse

AND- Proven ability (at least 10 years experience) in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting.- Experience in oncology and/or hematology (represents 75% of the focus)

PREFERRED QUALIFICATIONS- M.D., D.O., PhD, PharmD, Master’s Degree in life sciences or medical sciences- Minimum 8 years of experience in country clinical operations and/or regional study management experience- Experience in oncology and/or hematology (represents 75% of the focus)- Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research networks- In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines- Project and Program management including oversight of quality, study deliverables, budgets and timelines- Various therapeutic area knowledge- Fluency in written and spoken English and Fre- Clinical trial management systems and reporting tools- Utilization of Key Performance Indicators (KPIs)- Ability to work independently as well as in a team/matrix environment on multiple projects and countries- Analytical and problem solving skills- Decision making- Oral and written communication skills- Strategic operational planning and cross-functional leadership- Horizon scanning- Risk assessment and risk mitigation- Organizational skills: planning, time management, prioritization, delegation- Teamwork, collaboration and