Director, Study Evidence & Readiness

Amgen; Washington (District of Columbia); Vor Ort; USD 180.000 - 230.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan

Stock-based long-term incentives

Discretionary annual bonus program

Flexible work models

Benefits package including health/well

Zusammenfassung

Amgen seeks a Director of Study Evidence & Readiness to lead TMF Operations and Inspection Readiness across global clinical studies. You will ensure evidence is complete, retrievable, and inspection-ready, guiding strategy and cross-functional execution.

You will manage senior managers and build capability, align metrics, and drive improvement initiatives while partnering with stakeholders to meet portfolio needs and regulatory expectations.

Qualifikationen

• Doctorate or equivalent with extensive leadership experience in life sciences.
• Experience leading TMF operations and inspection readiness in global studies.
• Strong understanding of global GCP and regulatory expectations.

Aufgaben

• Set strategy for TMF Operations and Inspection Readiness.
• Lead and develop global teams; manage performance and succession.
• Oversee TMF health, evidence gaps, and inspection readiness across study portfolio.
• Plan department structure, budget, resources, and continuity.

Kenntnisse

Leadership experience

Cross-functional collaboration

Regulatory knowledge

Strategic planning

People management

Ausbildung

PhD

PharmD

MSc

BSc

RN qualification

Tools

TMF systems

Regulatory databases

Jobbeschreibung

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director, Study Evidence & Readiness

What you will do

Let's do this. Let's change the world. In this vital role you will lead the Study Evidence and Readiness function, encompassing TMF Operations and Inspection Readiness, to ensure that clinical studies are continuously able to demonstrate appropriate trial conduct through complete, reliable, retrievable, and inspection-ready evidence.

Responsibilities:

• Set the strategy and priorities for TMF Operations and Inspection Readiness, aligning day-to-day evidence stewardship with continuous inspection readiness.
• Lead and develop global teams, including line management of Inspection Readiness Senior Managers and Managers; set clear goals, manage performance and engagement, and build succession and capability plans.
• Provide integrated oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio; establish meaningful metrics, thresholds, and escalation recommendations.
• Plan and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity to meet portfolio needs.
• Lead improvement initiatives that strengthen evidence quality, completeness, retrievability, and readiness; represent the function in process improvement, standards development, and integration work.
• Develop and maintain effective TMF and inspection-readiness processes, policies, SOPs, work instructions, and related materials, applying current procedures, industry practice, and relevant regulatory expectations.
• Partner cross-functionally to resolve evidence issues, interpret trends, apply root-cause insights, and drive sustainable improvement.
• Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends; contribute to relevant leadership forums and governance committees.
• Support audits and inspections, including preparation, response support, and lessons learned for TMF and inspection-readiness process areas; build strong relationships with internal and external experts.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree & 4 years of directly related experience or equivalent OR
• Master's degree & 8 years of directly related experience or equivalent OR
• Bachelor's degree & 10 years of directly related experience or equivalent
• AND 4 years of direct managerial and/or leadership experience or equivalent

Preferred Qualifications:

• PhD, PharmD, MSc, BSc, or RN qualification.
• 11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO.
• Leadership experience managing direct reports, including management-level staff.
• Experience in TMF operations and inspection readiness, preparation, inspection support, or response.
• Experience managing or overseeing external clinical research vendors.
• Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness, along with risk-based oversight, evidence health, resource planning, and organizational capacity.
• Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics; able to build relationships, lead change, develop high-performing teams, and communicate clearly.

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, we'll support your journey every step of the way.

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.

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:

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

Application deadline

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

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.