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
