Sr. Director, Clinical Central Services and Innovation
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Clinical Central Services and Innovation (CCSI) organization is responsible for enabling the delivery of community based research through developed deep therapeutic area expertise and application of central capabilities including but not limited to logistics relative to patient centered capabilities (examples include but are not limited to study navigation, patient concierge services, central study coordinators); non-IMP (investigational medicinal product) supply planning and logistics delivery (examples include but are not limited to ancillaries, study start up kits, patient start up kits, visit specific kits, patient retention items, eCOA devices); community based delivery through centralized capabilities such as mobile research units and innovative location / site approaches to enable broader access to clinical trials with less burden for patients.
This group is within the Clinical Capabilities organization. Through strong partnership and collaboration across Clinical Design, Delivery & Analytics (CDDA) and the Business Units in all phases of development, this organization aligns delivery of capabilities to trial design needs globally. The group influences and partners with industry colleagues and regulators to shape the external environment and enable broader access to clinical trials. The Sr. Director promotes understanding of global regulations and the external environment impacting community-based delivery. This role establishes processes and practices for continual monitoring and oversight to ensure continuous quality, data integrity, human protection, undue influence, and privacy are maintained. Responsibilities include but are not limited to partnering with global functional leaders to translate therapeutic area and portfolio needs to discover, develop, and implement clinical central services in support of community-based research.
Central Clinical Services Leadership
- Responsible for the continued strategy, development, optimization, and oversight of Central Clinical Services capabilities.
- Continuously maintain a state of inspection readiness. Participate and perform duties required for internal and external inspections as well as supporting institutions / investigators and alternative site locations in inspection readiness initiatives.
- Make complex decisions that involve vendors, cross-functional areas, or are considerable risk.
- Build relationships to enable an optimized investigator and participant experience.
- Influence vendors on technology and service-related offerings.
- Lead new capabilities outlining key performance indicators and decision gates for continued usage and scale.
- Manage overall risk identification and mitigation within capability area.
- Define and manage budget for Central Clinical Services.
- Creates culture of customer centricity; ensures participant and site personnel issues are escalated appropriately
Enterprise Leadership and External Focus
Build strong functional networks with clinical leaders / representatives to integrate new or existing services and capabilities based on evolving portfolio and business needs.Influence the external environment including regulators, institutions, institutional review boards, ethics committees, investigators, vendors, etc.Drive continuous improvement, shared learning and process expertise between teams and across the organization.Responsible for identification of metrics evaluating participant, partner, investigator, and central rater experience.Identifies short- and longer-term trends impacting this capability area.People Management and Development
If applicable, recruit, develop, and retain a diverse, clinical, technical and operationally capable workforce.Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio.Build an organizational culture that fosters inclusion, innovation, and promotes diversity.Partner closely with CDDA leadership to effectively plan, forecast, and manage the portfolio and project work.Basic Requirements
Bachelor's degree in a scientific field or health-related field5 years' experience in Clinical Trials / Development and good working knowledge of Good Clinical Practice3+ years' experience in working with and managing CROs or external vendors for the execution of clinical trialsAdditional Preferences
Demonstrated leadership skills with ability to influence, achieve results through others and lead across the business and across regions / geographiesExperience in supervision, coaching and mentoring othersDemonstrated business acumen (financial oversight, business development, business planning).Effective communication (both verbal and written) and language skills ability to communicate effectively up and down in the organizationStrong organizational / planning skillsFluent in English [Fluency in Spanish is a bonus]Knowledge of country regulatory guidelines / requirements for clinical research conductStrong interpersonal skillsDemonstrated decision-making abilityAbility to develop and apply creative solutionsExperience in working cross-culturally and with virtual teams