- Manage direct reports, overseeing performance reviews, career progression, training, and engagement
- Lead activities pertaining to country and site identification, feasibility and country selection within a clinical study
- Partner with study team members, data analytics team and country teams to design and conduct global feasibility activities on time with high quality delivery.
- Ensure consistency of feasibility execution across the portfolio/pipeline including bridging gaps between local/central data
- Ensure clear timelines and expectations are aligned and communicated between data providers and study teams to expedite data insight deliverables and confirm the analysis timeline is coordinated with study team decision achievements. This includes initial enrollment timelines, footprint optimization, developing key assumptions, and establishing patient recruitment strategy potential, etc.
- Confirm the Global Feasibility Strategy includes relevant data insights and/or appropriate engagement from the Enrollment Lab, to support the successful operational execution of the Diversity Action Plans (where appropriate).
- Lead the collection of local internal and external data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, operational barriers) to define an optimal geographic country footprint and proposed sites for participation in a clinical study.
- In partnership with internal stakeholders- synthesize, interpret and integrate data and information to provide clear feasibility recommendations to further embed data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution.
- Drive operational readiness (funding status, resourcing triggers (CRAs, data teams, etc.)
- Facilitate the study baseline commitment & change process (country and study levels).
- Initiate and lead global feasibility continuous improvement efforts and initiatives.
- Support development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site) as well as the timing of key recruitment milestones.
- Doctorate degree & 2 years of directly related experience or equivalent, OR
- Masters degree & 4 years of directly related experience or equivalent, OR
- Bachelors degree & 6 years of directly related experience or equivalent, OR
- Associates degree & 10 years of directly related experience or equivalent, OR
- High school diploma / GED & 12 years of directly related experience
- M.D., D.O., PhD, PharmD, Masters Degree
- 10+ years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company
- Feasibility experience and/or country clinical operations experience
- Understands how data and analytics can inform study design and operational planning
- 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, including remote work arrangements, where possible
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Global Feasibility Senior Manager - Washington, United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Global Feasibility Senior Manager
Live
What you will do
Lets do this. Lets change the world. In this vital role you will own the development and execution of the feasibility strategy in partnership with clinical program team, global study management and cross-functional data teams to deliver a fully-optimized operational action plan. They will lead the successful delivery of the feasibility process (strategy plans, country selection, site identification, timelines, synthesis of feasibility insights) to expedite cycle times for all clinical programs assigned.
Key responsibilities include the following:
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Preferred Qualifications:
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising 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 including:
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
