Process, Systems and Strategic Integration, Executive/Snr Director, Clinical Delivery Capabilities (EMP)
Eli Lilly and Company
June 24, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Sr Director, Clinical Delivery Capabilities (CDC) – Process, Systems & Strategic Integration
Responsibilities:
- Lead EMP representation in cross-functional process governance; communicate process performance, compliance posture, and change.
- Maintain integrated view of CDC–CTF process interdependencies (data standards; system connectivity such as Vault Clinical, CT Registry, eTMF; role accountability).
- Drive automation/innovation and reflect EMP operational needs in enterprise design decisions.
- Monitor EMP delivery execution; surface process friction to CTF owners for improvement.
- Ensure EMP delivery processes align with ICH/regulatory requirements and internal quality standards.
- Own outsourcing process architecture for CRO/TPO delivery in compliance with Lilly quality systems and regulatory obligations; define frameworks, templates, capability requirements, and role/decision rights at handoffs.
- Shape inspection readiness for externally delivered activities; lead audit/inspection responses.
- Own acquisition/licensing/program integration framework; lead cross-functional workstreams and establish integration methodology (process adoption, system/data migration, quality/capability development); manage integration risk and decision gates.
- Support integration with TPO partners for exploratory/biopharmaceutics portfolio; lead/support external partnership operations and assessments.
- Lead and develop team; foster continuous improvement (kaizen).
Minimum Qualifications:
- Bachelor’s in a science field (or equivalent); 10+ years pharma experience managing clinical studies (ideally exploratory/biopharmaceutics) and 3+ years in a leadership role.
- Experience with regulations/guidelines for clinical trials.
- Project/time management; coaching/mentoring; travel up to 10%.
Preferred Qualifications:
- Cross-cultural/virtual collaboration; strong influencing and relationship-building.
- Strong organization, interpersonal skills, reasoning, attention to detail, negotiation, critical thinking, problem solving, analytics.
Compensation/Benefits (as stated):
- Anticipated wage: $156,000–$228,800.
- Eligible for company bonus and comprehensive benefits (401(k), pension, vacation; medical/dental/vision; flexible benefits; life insurance; time off/leave; well-being benefits).
Responsibilities:
- Lead EMP representation in cross-functional process governance; communicate process performance, compliance posture, and change.
- Maintain integrated view of CDC–CTF process interdependencies (data standards; system connectivity such as Vault Clinical, CT Registry, eTMF; role accountability).
- Drive automation/innovation and reflect EMP operational needs in enterprise design decisions.
- Monitor EMP delivery execution; surface process friction to CTF owners for improvement.
- Ensure EMP delivery processes align with ICH/regulatory requirements and internal quality standards.
- Own outsourcing process architecture for CRO/TPO delivery in compliance with Lilly quality systems and regulatory obligations; define frameworks, templates, capability requirements, and role/decision rights at handoffs.
- Shape inspection readiness for externally delivered activities; lead audit/inspection responses.
- Own acquisition/licensing/program integration framework; lead cross-functional workstreams and establish integration methodology (process adoption, system/data migration, quality/capability development); manage integration risk and decision gates.
- Support integration with TPO partners for exploratory/biopharmaceutics portfolio; lead/support external partnership operations and assessments.
- Lead and develop team; foster continuous improvement (kaizen).
Minimum Qualifications:
- Bachelor’s in a science field (or equivalent); 10+ years pharma experience managing clinical studies (ideally exploratory/biopharmaceutics) and 3+ years in a leadership role.
- Experience with regulations/guidelines for clinical trials.
- Project/time management; coaching/mentoring; travel up to 10%.
Preferred Qualifications:
- Cross-cultural/virtual collaboration; strong influencing and relationship-building.
- Strong organization, interpersonal skills, reasoning, attention to detail, negotiation, critical thinking, problem solving, analytics.
Compensation/Benefits (as stated):
- Anticipated wage: $156,000–$228,800.
- Eligible for company bonus and comprehensive benefits (401(k), pension, vacation; medical/dental/vision; flexible benefits; life insurance; time off/leave; well-being benefits).