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 39,000 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 COO (PPM/CPM Advisor) is accountable for the following:
Implementation of a product strategy for HCP and payer platforms that provide patient stratification, decision support, and intervention recommendation/delivery for both the open- and closed-loop programs.
Translation of the IT, marketing, medical, PR&A, and regulatory needs for the platforms into a single integrated plan.
Ownership of the evidence plan needed to support regulatory approval, differentiate the platforms, secure access within target geographies, and ultimately achieve commercial success.
Delivery of integrated plan deliverables for the platforms in alignment with the global strategy and plan (including oversight and tracking of budgets and resources).
Creation of a high-quality, high-performance culture within the assigned team, including performance of cross-functional/corporate processes, alliance management, affiliate relationships and team culture.
Application and integration of key project management processes and tools across teams to deliver platforms value on time, on budget, within scope, and with high quality.
Facilitation of cross-functional communication, proactive identification and mitigation of project risks, and timely documentation of key platform information and decisions.
Management of third-party relationships (including partnerships), including operational leadership and excellence in moderately to highly complex external partnerships.
Leadership of special initiatives specifically targeted at developing a phase-appropriate evidence-generation capabilities.
The COO reports to the Global Platform Leader (HCP & Payer Platforms), and has indirect supervisory responsibility for project management associates/consultants.
1. Enable strategy for assigned HCP & payer platforms (20%):
Ensure the strategy considers operational feasibility.
Ensure project scope (functionality, resources, etc.) is aligned with the strategy.
Ensure the strategy includes a clear lifecycle plan that guides future investment.
2. Develop and implement integrated plans for assigned HCP & payer platforms (20%):
Lead creation of an aligned cross-functional plan for the platforms that provides the foundation for operational plans (IT, Device Development, Marketing, PR&A, Regulatory, etc.).
Lead creation of a roadmap that provides clear visibility to all critical decisions, and ensure all operational plans proactively anticipate and facilitate these decisions, consistent with quality decision-making principles.
Lead creation and oversight internal and external communication plans to ensure alignment with strategy, and key milestones/events, including scientific data disclosures.
Lead creation and oversight of an integrated risk management plan, including mitigation and contingency plans, and ensure full disclosure of risks to management in a timely fashion.
Lead preparation and presentation of strategic and operational governance reviews/approvals, in partnership with the Global Platform Leader.
3. Develop and implement clinical plan for HCP & payer platforms (20%):
NOTE: Given the relatively small (but critically important) clinical scope and budget for connected care projects, the COO and CPM Advisor roles are combined into a single role with accountability for both the clinical plan and overall integrated plan.
Lead special initiatives specifically targeted at developing a phase-appropriate clinical development capability for device and/or connected care projects, as part of broader MDU capabilities.
Lead creation of an aligned clinical plan for the platforms that both aligns to product strategy and considers operational feasibility, in partnership with Medical and MDU functional leadership.
Lead assessment of feasibility of clinical trial and non-trial plans, based on external benchmarking and feedback from potential clinical sites and external development partners.
Lead sourcing activities to support the evidence-generation plan, in partnership with Health Outcomes, Medical, and Sourcing/Procurement, where appropriate.
Lead partnership with third parties (e.g. CROs) to drive for increased flexibility and efficiency to deliver evidence-generation plans in a cost-effective manner.
4. Deliver results for assigned HCP & payer platforms (20%):
NOTE: Given the very large CMC/device and capital budgets for connected care, as well as the need to trigger spend based on clinical data and regulatory input, the COO will need to collaborate very closely with the PDPM/DDR&D Program Advisor role in the operation of the cross-functional team.
Lead the cross-functional team, in close partnership with the GDD Leader and PDPM/DDR&D Program Advisor, to meet or exceed overall project goals with quality, on strategy, on scope, on time, on budget.
Lead creation and oversight of Critical Chain-based team culture that works in focused fashion to the shortest possible cycle time, yet is agile and flexible in response to technical and operational contingencies.
Lead creation and oversight of an integrated project budget that aligns functional resources (FTEs and funding) over a minimum 8-quarter planning horizon, and clearly represents expected cost variability.
Lead creation and oversight of team processes for scope, cost, timeline, and risk management by using appropriate tools and technique, including change control.
Lead project monitoring and status reporting to ensure achievement of key project deliverables in alignment with the project plan and in compliance with corporate quality standards.
5. Contribution to Project Management Excellence (10%):
Ensure shared learning, process improvement, and incorporation of best practices both from within Lilly and across the industry into team processes, tools, and training.
Ensure continual process improvement for both the platforms and connected care product development more generally (e.g. after action reviews).
6. People (10%):
Ensure development of team members, particularly those with less experience and/or new to Lilly, by being an active coach and mentor.
Ensure an environment of co-operation and mutual respect within the team and across functional boundaries, and motivate team to achieve objectives in the face of adversity or roadblocks.
Ensure a positive and productive working environment with external partners and vendors, in partnership with Alliance Management
Bachelor's degree in a health care-related, scientific or engineering field; plus 8+ years of direct work experience in drug and/or delivery device development.
Advanced degree in a health care-related, scientific or engineering field; plus 5+ years of direct work experience in drug and/or delivery device development.
Prior Cross-Functional Project Leadership experience (COO and/or PTL), with a strong understanding of value management and quality decision-making principles.
Experience in clinical practice, clinical research, and device/drug development processes (10+ years), with a strong focus and deep understanding of connected care, telehealth, clinical data standards, clinical data flow, and related regulatory requirements and expectations (e.g., ICH, GCP, CDISC, SDTM, HL7).
Excellent influence skills, including the ability to influence team members and wide range of internal/external stakeholders without direct personal authority.
Excellent organizational change management skills, including the ability to “work on the Lilly system” while at the same time “working in the Lilly system”.
Excellent communication skills, including the ability to communicate clearly and succinctly with team members and leadership.
Excellent critical thinking and problem-solving skills, including the ability to anticipate and recognize problems, diagnose root causes, and take corrective action to prevent recurrence within the team.
Excellent self-management and organizational skills, including the ability to manage workload, set personal and team priorities and adjust as needed.
Excellent learning agility, including the ability to adapt quickly to change, and work within and across a large number of different teams with varying cultures, styles, issues, complexity, and levels of detail.
Excellent interpersonal and teambuilding skills, including the ability to develop teamwork between team members with diverse interpersonal styles, and deliver effective coaching and feedback where needed.
Excellent business acumen, including the ability to leverage business principles within the team while maintaining a corporate view of overall portfolio.
2. Project Management Expertise:
Excellent command of project management tools/processes, as adapted by both Lilly and partners/vendors (e.g. Agile vs. Critical Chain vs. Critical Path), based on prior project management experience.
Excellent ability to manage projects in a virtual environment, including collaborations involving external partners, vendors, and institutions.
Prior delivery device, connected system, and/or development experience strongly preferred.
Prior data flow, data quality, data interchange, data mining, and/or data visualization experience.
Prior IT project management experience in agile methodology highly desirable.
Integrated workplace environment at either Cambridge Innovation Center or Lilly Technology Center.
Potential for flex time/schedule.
Significant time spent at Lilly Corporate Center with team members and stakeholders.
Routine domestic travel to Cambridge, MA and/or Indianapolis, IN (depending on primary location), as well as other partners/vendors; estimated to be at least monthly.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status