Program Lead, Clinical Delivery - EMP

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.
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* Purpose:

** The purpose of the Program Lead, Clinical Delivery is to lead the creation and execution of the exploratory and bio-pharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. The Program Lead, Clinical Delivery is responsible for planning and delivering exploratory and bio-pharmaceutics clinical trial and submission achievements on time and on budget throughout the molecule lifecycle.  

The Program Lead, Clinical Delivery is responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact for trials from design through execution, including timeline creation and management, outsourcing plan, vendor management (including oversight of the operational results), and budget management. The Program Lead will seek knowledge from internal and external sources and use this information to shape development plans and innovation opportunities.
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* Primary Responsibilities:

** This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Collaborate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Scientific and Therapeutic Area Expertise
* Leads the development of the clinical asset strategy for phase 1 maximising quality decision making principles.
* Understands assigned therapeutic area including trial designs, risks and execution challenges and procedures.
* Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications, and manuscripts.
* Stays up to date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and protocols.
* Maintains knowledge of operational requirements to effectively plan exploratory and bio-pharmaceutics clinical development studies and submissions e.g., FHD (First Human Dose) requirements, detail of operations to deliver critical path studies and submissions.

Clinical Project Management:
* Leads and has expertise in the implementation and integration of clinical project management processes and tools.
* Works with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial results.
* Develops and maintains up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team.
* Partners with the financial organization, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process.
* Proactively identifies and communicates clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates, and leadership.

Clinical Delivery:
* Accountable and responsible for oversight of clinical trial operations and delivery of clinical project achievements on time, on budget
* Create and manage implementation timeline and clinical trial activities
* Involved in selection process and management of vendors, ensuring day to day oversight for operational deliverables of external network of vendors to…