Development Transformation Lead - Director

April 16

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Amgen

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Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Join Amgen’s Mission of Serving Patients • Help make a lasting impact on the lives of patients • Collaborate cross-functionally with stakeholders across multiple teams • Oversee external partners that will develop the documentation • Lead the process documentation transformation for end-to-end clinical trial execution • Implement a modern, fit-for-purpose documentation framework • Optimize Standard Operating Procedures (SOPs) and training materials • Ensure regulatory inspection readiness and compliance • Drive change impact analysis and mapping for clinical trials • Partner with training and change management leads • Establish accountability structures for document lifecycle management • Measure key performance metrics of documentation effectiveness

🎯 Requirements

• Doctorate degree and 4 years of relevant experience OR Master’s degree and 7 years of relevant experience OR Bachelor’s degree and 9 years of relevant experience • Bachelor’s 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 large-scale 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 cross-functional 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 problem-solving 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 execution (e.g., CTMS, eTMF, workflow automation tools). • Background in large-scale organizational transformation, change enablement, or process optimization initiatives.

🏖️ Benefits

• 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, • 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, including remote and hybrid work arrangements, where possible