Job Description

Accountabilities

Develop, implement and maintain an integrated site engagement and operational role at

key/targeted sites in line with Global Development pipeline to support strategic global study

strategy plan to accelerate development of marketed products and early pipeline assets.

Maintains an effective collaborative partnership with all stakeholders, ensuring aligned and

synergistic approach to site's experience with Amgen interactions.

Responsibilities

Leadership of Operational Site Engagement Align and lead identification and strategic partnership with key sites to implement a

collaborative initiative for clinical trial execution.

Accountable for strategic long-term operational partnerships with key sites, provide local

intelligence, and contribute to maintaining a consistent and coherent voice as part of

Amgen's overarching engagement strategy. Collaborate with other cross functional roles

for 'tailored' global execution of study(ies).

Proactive and accountable to drive expansion of Amgen's strategic relationships and

meet clinical operational needs as subject matter expert.

Primary site-facing, cross-study, operational decision-maker between Amgen and

designated key sites for the purposes of establishing Amgen-Institutional operational

working practices.

Maintain country expertise, site knowledge to navigate with Amgen and sites with

targeted and tailored communication.

Develop, drive and monitor site operational strategies and performance across all

therapeutic areas and studies, in strong collaboration with Amgen stakeholders.

Assimilate and report external feedback to evaluate and propose operational process

efficiencies, focus and direction for site collaboration on clinical trials.

Orchestrate relationship management and strong internal alignment with Amgen

stakeholders (medical, study management, site management, and other key -

stakeholders) to drive operational efficiencies.

Strong 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 KPIs to Key Stakeholders, e.g., DOM, DFM, CTOM,

Study Managers etc.

Locally accountable for key, targeted sites execution of clinical studies Build and develop strong relationships with key sites to engage with Amgen as Choice

for clinical trial participation, to effectively advance site operational engagement and

better understand current site processes to enhance our clinical trial execution.

Regular communication with key sites to connect on all trials/all stages to determine

trends and opportunities and enhance site's experience with Amgen. On-site visits as

appropriate (per site and situation).

Maintaining quick and direct access to key sites' leadership & operation teams, point of

escalation for operational, cross-study potential barriers and operational issues.

Internal point of contact to navigate working with key sites, and to help key sites navigate

working with Amgen.

Centralize and socialize site intelligence technology, such as working practices,

operational documents, to enhance clinical trial efficiencies at site.

Participation in cross-functional task forces / process improvement groups. GSO quality management Actively participates in role forums including local and global functional and cross functional

initiatives.

Participates in Functional Management Team (FMT) Meetings as required and applicable

country-level project review meetings.

Qualifications

The knowledge and skills necessary to perform the duties of this position are

typically acquired through the following combination of education, experience

and knowledge, or the equivalent.

Basic Qualifications

BA/BS/BSc or RN Work 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)

Preferred Qualifications

M.D., D.O., PhD, PharmD, Master's Degree Country clinical operations experience and/or regional study management

experience

Expertise and in-depth understanding of site engagement with clinical trials, or

building and/or coordinating community research networks

Knowledge

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 Clinical trial management systems and reporting tools Utilization of Key Performance Indicators (KPIs)

Competencies

Commitment to uphold ethics and the Amgen values 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 Issue management and escalation Project management Organizational skills: planning, time management,

prioritization, delegation

Teamwork, collaboration and relationship building skills

across geographic areas, including: networking, negotiation

and influencing skills across all levels with both

internal/external stakeholders

Change management skills and learning ability Patience, flexibility and high tolerance for ambiguity and

change.