Director - Design and Innovation

D&I AIN Director

Career Category

Research

Job Description

Director, Design & Innovation

What you will do

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. The Director, Design & Innovation provides strategic, operational, and people leadership for Design & Innovation capabilities based in Amgen India. This role is accountable for building, managing, and scaling India-based teams across Biomedical Data Stewardship (BMDS), Centralized Statistical Monitoring (CSM), Safety Statistics (SS), and Global Randomization & Blinding (GRB).

The position serves as the primary India-based leadership interface to global Design & Innovation leaders as well as cross-functional AIN senior leadership stakeholders within and outside of CfDA AIN, ensuring alignment to global strategy while enabling efficient, high-quality execution and capability growth at AIN. While not all functions may be fully represented in India initially, this role is responsible for planning and supporting the expansion of Design & Innovation presence over time.

Accountabilities:

• Provides leadership for Design & Innovation functions based in India, ensuring delivery of high-quality, compliant, and value-added outputs aligned with global standards and strategy.
• Serves as the primary people leader and managerial owner for India-based staff across BMDS, CSM, SS, and GRB.
• Acts as a strategic partner to global Design & Innovation leaders, supporting execution of the global vision while representing India capabilities, capacity, and growth opportunities.
• Drives adoption of innovative design, statistical, data stewardship, centralized statistical monitoring, safety monitoring, and randomization/blinding approaches in collaboration with global function heads.
• Ensures consistent application of Amgen policies, SOPs, and controlled documents across all India-based Design & Innovation activities.
• Supports capability development, talent pipeline growth, and succession planning for Design & Innovation functions in India.
• Provides oversight of resourcing, prioritization, and workload balancing across India-based teams.

This position is currently located at Amgen India (Hyderabad).

Responsibilities:

Strategic & Operational Leadership

• Translate global Design & Innovation strategy into executable plans for India-based teams.
• Support delivery of innovative statistical methodologies, data standards, centralized statistical monitoring, safety monitoring, and randomization/blinding services.
• Partner with global leaders to identify opportunities for expanding Design & Innovation capabilities and scope at AIN.
• Ensure operational excellence, quality, and regulatory compliance across all supported functions.

People Leadership & Talent Development

• Recruit, develop, coach, and retain high-performing Design & Innovation staff in India.
• Build a strong leadership bench across BMDS, CSM, SS, and GRB in alignment with future-state organizational needs.
• Foster a collaborative, inclusive, and high-accountability culture consistent with Amgen values.
• Oversee performance management, development planning, and career progression for direct reports.

Cross-Functional & Global Collaboration

• Act as the primary liaison between India-based Design & Innovation and CfDA teams and global counterparts.
• Collaborate with Development Therapeutic Areas, Global Biostatistics, Global Patient Safety, Dev IS, CfOR, PMED, and other partners as needed.
• Support global and local AIN initiatives related to innovation, process improvement, technology adoption, and standards implementation.

Governance, Quality & Compliance

• Ensure adherence to regulatory expectations, internal controls, and quality standards.
• Support development, review, and implementation of policies, SOPs, and standards relevant to Design & Innovation activities.
• Participate in audits, inspections, and quality reviews as required.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation.

Basic Qualifications

• Master’s degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or related scientific discipline
• At least 8 years of experience in the pharmaceutical, biotechnology, or medical research industry.
• Demonstrated experience in people management, including direct reports.
• Strong written and verbal English communication skills.
• Experience working effectively in a globally distributed, cross-cultural environment.

Preferred Qualifications

• Doctorate degree in Statistics, Biostatistics, or related field.
• Experience across one or more of the following domains: statistical innovation, data stewardship, safety statistics, centralized statistical monitoring, or randomization and blinding.
• Working knowledge of drug development across multiple phases.
• Experience with regulatory submissions and interactions.
• Demonstrated success leading multidisciplinary teams in a matrixed organization.
• Experience driving innovation, process improvement, or capability build-out.
• Experience developing or implementing policies, SOPs, and standards.
• Budget, resource planning, and vendor oversight experience.
• External visibility through industry groups, forums, or professional organizations (nice to have, not mandatory).

Competencies:

Scientific / Technical Leadership

• Strong foundational understanding of clinical statistical principles, and/or clinical data standards.
• Ability to guide and challenge teams on fit-for-purpose approaches without needing to be the deepest technical expert in every area.
• Appreciation for innovative methods and emerging industry trends.

People & Organizational Leadership

• Proven ability to lead, develop, and motivate diverse teams.
• Strong coaching mindset with a track record of growing talent.
• Comfortable leading through influence in a matrixed, global environment.

Business Acumen & Strategic Thinking

• Understands how Design & Innovation capabilities support broader development and business objectives.
• Able to balance innovation, quality, speed, and operational efficiency.
• Sound judgment in prioritization and resource allocation.

Communication & Influence

• Communicates complex topics clearly and credibly to varied audiences.
• Builds trust and effective partnerships across functions and geographies.
• Able to influence without formal authority.

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and develop within our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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Experience Level

Executive Level