About the Job:
The Associate Director Clinical Delivery Program Lead is responsible for leading the creation and execution of clinical development plans at a molecule level.
This role oversees technical leadership and operational oversight of clinical research trials within the development plan, ensuring timely delivery of exploratory and biopharmaceutics clinical molecule and submissions milestones on time and on budget throughout the molecule lifecycle.
Key responsibilities include planning and delivering clinical trial operations, managing vendors, patient recruitment and retention, and budget management.
The Associate Director will also be responsible for seeking knowledge from internal and external sources to shape development plans and identify continuous improvement opportunities.
Primary Responsibilities:
* Lead the development of the clinical asset strategy for phase 1 leveraging quality decision making principles.
* Understand assigned therapeutic area including trial designs, risks and execution challenges and best practices.
* Provide 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.
* Maintain knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions.
Clinical Project Management:
* Lead and have expertise in the implementation and integration of clinical project management processes and tools.
* Work with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables.
* Develop and maintain up-to-date clinical plan timelines and process maps ensuring communication of progress to the broader molecule team.
* Partner with the financial organization, cross-functional partners, and geographies to develop and manage the overall clinical budget for the molecule level book of work.
* Proactively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates and leadership.
Clinical Operations:
* Accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget.
* Create and manage implementation timeline and clinical trial activities.
* Involved in selection process and management of vendors, providing day to day oversight for operational deliverables with external network of vendors.
* Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external).
Qualifications:
* Bachelor's degree in a science related field from an accredited college or university.
* 3 years' experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ years preferred).
Lilly is an Equal Opportunity Employer:
Lilly 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.