Executive Director, Global Site & Study Operations, Americas

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Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions.

As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Executive Director Global Site Study Operations Americas

What you will do

Lets do this. Lets change the this vital role as Executive Director Global Site Study Operations America you will be accountable for regional Study & Site Operations leadership across the Americas clinical trial portfolio. This role provides enterprise-level strategic direction operational oversight people leadership and cross-functional influence to ensure high-quality timely compliant and predictable trial delivery. The role leads regional and country/hub leaders shapes site engagement and monitoring strategies and represents the region in global governance and portfolio decision-making forums.

Key Responsibilities

• Oversees countries and regions within the Americas including US Canda and LATAM.

• Operates at an enterprise leadership level and is expected to combine portfolio-level strategic leadership operational accountability people leadership and cross-functional influence.

• Initiation management quality and completion of Phase I-IV clinical trials in the region ensuring timely high-quality delivery in compliance with ICH-GCP regulatory requirements and company policies.

• Guiding the organization on modern site-monitoring approaches and associated resource strategies.

• Represent the region and/or GSSO in enterprise forums providing insights that inform portfolio program and study-planning decisions

• Build and develop a high-performing Country/Hub head team as strategic leaders creating a culture of accountability innovation and operational excellence in their regions.

• Champion innovation and continuous improvement in start-up approaches embedding digital solutions predictive analytics and harmonized ways of working across the global portfolio.

Leadership and Delivery

• Accountable for implementing the Regional Study & Site Operations strategy ensuring that study resources are appropriately allocated according to global operations and priorities.

• Optimize deployment of resources including internal and staff augmented across clinical programs.

• Interpret and cascade GDO strategies into consistent regional andcountry-level delivery of studies site engagement and monitoring against quality standards and other cross-functional processes and initiatives balancing standardization with local/regional adaptability.

• Provide executive oversight of high-risk or strategically important clinical programs.

• Act as the GSSO escalation point for study risks and issues coaching teams through mitigation strategies and scenario planning ensuring timely resolution and visibility.

• Build and sustain a CRA monitoring organization including resourcing strategies and portfolio considerations while ensuring monitoring standards and organizational capabilities are in place.

  • Ensure monitoring strategies incorporate in partnership with relevant cross-functional capabilities the appropriate use of centralized monitoring on-site and remote monitoring targeted SDR/SDV and risk/quality indicators and thresholds.

• Lead through an evolving site engagement model executing strategies that strengthen relationships with clinical research sites improve site experience and enhance site performance across clinical development programs.

• Holds decision-making authority for all study and site operations in the region including resource allocation budget utilization and vendor performance.

• Maintain oversight of the regional clinical trial portfolio including study start-up enrollment execution database lock and study closeout. Coach and mentor teams in management of challenges and issue escalation.

• Ensure appropriate inspection readiness throughout the clinical trial lifecycle and follow through to audits and inspections in the region.

• Represents GSSO and/or the region in global governance bodies with delegated authority to influence portfolio decisions timelines and resourcing.

Capability Building & People Leadership

• Lead coach and develop regional and country Study & Site Operations leaders including performance management succession planning and leadership bench development.

• Build the organizational capabilities resourcing and operating model needed to meet current and future regional portfolio requirements.

• Foster a high-performing inclusive accountable and patient-focused culture across geographically distributed teams.

• Lead organizational changes and enable adoption of new operating models technologies monitoring approaches and clinical development practices.

• Foster a culture of accountability collaboration inclusion quality continuous improvement and patient focus.

• Lead organizational change and support adoption of new operating models technologies and clinical development approaches.

Operational Excellence & Cross-Functional Engagement

• Lead coach and develop regional and country Study & Site Operations leaders including performance management succession planning and leadership bench development.

• Build the organizational capabilities resourcing and operating model needed to meet current and future regional portfolio requirements.

• Foster a high-performing inclusive accountable and patient-focused culture across geographically distributed teams.

• Lead organizational changes and enable adoption of new operating models technologies monitoring approaches and clinical development practices.

• Identify opportunities to simplify processes improve productivity and increase predictability of clinical trial delivery.

• Use data and performance insights to drive decisions and continuous improvement.

• Lead or sponsor regional and global clinical operations transformation initiatives.

• Embed a center of excellence mindset encouraging knowledge-sharing and best practice adoption globally.

Stakeholder Engagement & Influence

• Partner with leaders across Clinical Development Operations Regulatory and Regions to ensure study start-up strategy enables trial success and resources required to execute are assigned and aligned to GSSO. Maintain and strengthen cross-functional and global business relationships representing GSSO.

• Act as a visible change leader promoting GSSO as a strategic enabler of faster more predictable clinical trial execution and drive cross-functional sponsorship.

• Cultivate leadership and capability across geographies to build resilient empowered teams that consistently deliver results.

Authority

• Accountable for regional level oversight and delivery of clinical trials.

• Holds line management authority for regional and country operations leaders including performance management talent development succession planning and capability building.

• Sets regional delivery goals operating expectations and performance standards across study start-up site engagement monitoring execution and closeout.

• Capability build talent and performance management and acting as a liaison for cultural differences within region.

Outputs

• Successful and timely trial delivery across the region with inspection-ready quality.

• Cohesive and aligned execution across countries with consistent quality and compliance.

• Sustained regionalinvestigator and site engagement enabled through consistent country/hub-level engagement strategies driving strong patient recruitment and retention.

• High-performing regional team with strong leadership empowered Country Heads acting as effective strategic representatives in their geographies.

Competencies

• Adept at navigating cross-geographic and cultural dynamics and leading efficient global teams. Demonstrated ability to motivate geographically dispersed teams inclusively and drive strategy and execution.

• Experience in delivering portfolio/cross-study level budgets timelines and performance metrics (time cost quality) aligned to global / functional priorities.

• Collaborate with global and regional leadership to ensure effective country and site strategies guiding study start up inspection and delivery.

• Proficient in overseeing resource and budget allocation in accordance with functional financial principles ensuring optimal resource planning aligned with global clinical priorities.

• Experience in assessing internal capabilities and identifying key capabilities proficient in driving and leading continuous improvement initiatives for teams working practices ensuring cross-functional adoption of new processes.

• Experience leading organizations through cross-functional change initiatives including identifying solutions to complex problems driving innovation and evolving strategies and structures to meet future business needs.

• Proven ability to foster impactful cross-functional collaboration through exceptional communication and influence.

• Enterprise pro-active thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions.

• Build strong partnerships with Clinical Development Medical Regulatory Affairs Safety Biometrics Data Management Clinical Supply Quality and other functions.

• Communicate portfolio performance risks and strategic recommendations clearly to senior leadership.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate degree & 6 years of global site study experiences OR

• Masters degree & 10 years of global site study experiences OR

• Bachelors degree & 12 years of global site study experiences AND

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

Preferred Qualifications:

• Bachelors degree in life sciences pharmacy nursing medicine or a related discipline required; advanced degree preferred.

• 15 years of progressive experience in pharmaceutical biotechnology CRO or clinical research organizations.

• Extensive clinical operations and study management experience across multiple phases of clinical development.

• Significant leadership experience managing managers and/or large geographically distributed clinical operations organizations inclusive of a monitoring organization.

• Demonstrated experience overseeing complex global or regional clinical trial portfolios.

• Demonstrated experience with CRO/vendor governance outsourcing models budget management and resource planning.

• Track record of leading organizational change and improving clinical operations performance.

• Strong knowledge of ICH-GCP clinical development processes and applicable regulatory requirements. Experience supporting regulatory inspections and clinical quality management.

• Experience working for or overseeing clinical research vendors (CROs central laboratories imaging vendors etc.

• Experience managing clinical operations across relevant geography / region including strong understanding of local regulatory requirements around clinical trials.

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected inclusive and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients staff and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $263760 - $356852. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts.

• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range