Director, Study Evidence & Readiness

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 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.

Lets do this. Lets change the 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.

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
• Masters degree & 8 years of directly related experience or equivalent OR
• Bachelors 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.

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 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.

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.

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 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.

Salary Range