Development Transformation Lead Director

Career Category

Job Description

Join Amgens Mission of Serving Patients

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. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. 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 awardwinning 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.

Development Transformation Lead Director

What you will do

Lets do this. Lets change the world. In this vital role you will collaborate crossfunctionally with stakeholders across Clinical Development Clinical Operations Quality Transformation and Training/Knowledge Management teams while also overseeing external partners that will develop the documentation. This is a highimpact role critical to ensuring regulatory inspection readiness and effective adoption of new ways of working across the organization.

We are seeking a strategic and experienced leader to drive the process documentation transformation for endtoend clinical trial . This role will lead the strategy and implementation of a modern fitforpurpose documentation framework aligned with evolving regulatory expectations and industry best practices. A core focus is to optimize content is included in Standard Operating Procedures (SOPs) guidance documents training materials and knowledge management systems that incorporate industry best practices that enable compliance to GCP principles by enhancing usability for staff.

Responsibilities

Lead EndtoEnd Process Documentation Framework:

• Design and implement a comprehensive documentation framework for clinical trial processes integrating changes from technology enablement and operating model updates.

Elevate a Controlled Document Strategy:

• Contribute to and implement R&D standards for document types including SOPs work instructions guidance documents and training content ensuring alignment with regulatory requirements and internal quality expectations with a focus on logical flows and linkages.

Liaison of Cross Functional Clinical Trial Processes:

• Solicit and identify operational dependencies impacting documentation design and implementation from deep clinical trial experts to shape process transformation strategies.

Oversee External Vendors and Consultants:

• Direct partner vendors providing technical writing business process mapping and change management support. Ensure outputs are aligned with strategic goals and delivered on time.

Enable CrossFunctional Process Alignment:

• Collaborate with business process owners (BPO) transformation leads Quality and QMS teams and learning and development partners to ensure documentation supports process clarity compliance and usability.

Drive Change Impact Analysis and Mapping:

• Lead the tracking and reconciliation between futurestate and currentstate process taxonomy. Develop and implement a systematic approach for tracking and mapping implementation of process changes on trials newly starting up or migrating to new processes

Enable Operational Excellence:

• Partner with training and change management leads to ensure new or updated documentation enables effective process understanding critical thinking and behavior change that drive collectively own operational excellence across all roles.

Ensure Regulatory Compliance and Inspection Readiness:

• Ensure all documentation supports GxP compliance and inspection readiness. Maintain a high standard of quality traceability and audit ability.

Drive Blank Sheet and Holistic Thinking:

• Take a forwardthinking clean slate approach to design futurestate documentation and processes that are usercentric intuitive and connected across functions.

Sustain Process Documentation Effectiveness:

• Establish accountability structures for business process owners to support document lifecycle management including periodic review and updates to ensure ongoing relevance and compliance. Measure key performance metrics of documentation effectiveness in conjunction with BPOs (e.g. User Readability Process Compliance Approach Consistency and Speed to Contribution)

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:

• Doctorate degree and 4 years of relevant experience OR

• Masters degree and 7 years of relevant experience OR

• Bachelors degree and 9 years of relevant experience

Preferred Qualifications:

• Bachelors degree required; advanced degree (PhD PharmD MBA or MS) preferred in a scientific operational or regulatory discipline.

• 10 years of experience in clinical development clinical operations or clinical quality assurance within pharmaceutical biotech or CRO environments.

• Demonstrated experience leading largescale process transformation and change management in a regulated (GxP) environment.

• Strong knowledge of controlled document management frameworks strategies and inspection readiness principles.

• Proven ability to lead crossfunctional initiatives manage complexity and influence across a matrixed organization.

• Experienced in vendor operational oversight and working with external experts to bring in industry best practices.

• Comfortable with ambiguity and building frameworks from the ground up; strong strategic and analytical thinking and problemsolving skills with demonstrated ability to bring structure to vaguely defined problems.

• Excellent written and verbal communication skills; effective at stakeholder engagement with solid ability to drive decisions and change management.

• Familiarity with Quality Management System (QMS) principles and digital learning platforms (e.g. LMS Confluence knowledge bases).

• Experience aligning process design with digital platforms that support clinical trial (e.g. CTMS eTMF workflow automation tools).

• Background in largescale organizational transformation change enablement or process optimization initiatives.

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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove ageidentifying 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.

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.

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