Eli Lilly and Company
Associate Director, Clinical Trial Program Lead
Eli Lilly and Company, Indiana, Pennsylvania, us, 15705
Associate Director, Clinical Trial Program LeadApply
Locations: Ireland, Cork
Time Type: Full time
Posted on: Posted Yesterday
Job Requisition ID: R-59883
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.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
About the Job:
The purpose of the Associate Director Clinical Delivery Program Lead is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.
The Associate Director Clinical Delivery Program Lead is responsible for the planning and delivery of the exploratory and biopharmaceutics clinical molecule and submissions milestones on time and on budget throughout the molecule lifecycle, as well as being responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact from trial design through execution and close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management.
Dependent on the operational/resource model chosen and influenced by the needs of the clinical development program, the Associate Director may be assigned additional trial level management support from internal or external resources. The will seek knowledge from internal and external sources and use this information to shape development plans and 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.
Stay informed & familiar with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.
Maintain knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions e.g. FHD requirements, detail of operations to deliver critical path 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 (if appropriate) 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 including initiation and management of the change process.
Proactively identify and communicate clinical risk assessments 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 to ensure on time and on budget clinical project deliverables.
Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward.
Partner with regulatory and medical to ensure safety management and monitoring processes are implemented.
Communication and Team Management:
Influence and work with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.
Manage key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).
Effectively and reliably communicate and influence at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders.
Leadership:
Collaborate effectively with colleagues at all levels; able to work with, and deliver, through others.
Skilled at working through ambiguity and effective problem-solving/solution-oriented skills to help develop and evaluate molecule level strategies from lead to legacy.
Successful in persuasion, influence, and negotiation skills in a matrix environment.
Foster spirit of learning agility, strategic thinking and the ability to think differently to incorporate new learning.
Contribute to the development of others by being an active source of constructive coaching and feedback to co-workers.
Minimum Qualification Requirements:
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).
Other Information/Additional Preferences:
Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
Advanced scientific degree.
Strong leadership and networking skills.
Early Phase (Phase 1) experience preferred.
Vendor management and contracting experience.
Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates).
Ability to influence and oversee TPOs to enable delivery of trial level deliverables.
Demonstrated knowledge and experience with project management tools and processes.
Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.
Excellent oral and written communication skills; able to communicate clearly and with team members and leadership.
Ability to travel (up to 10% expected).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
#WeAreLilly
#J-18808-Ljbffr
Locations: Ireland, Cork
Time Type: Full time
Posted on: Posted Yesterday
Job Requisition ID: R-59883
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.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
About the Job:
The purpose of the Associate Director Clinical Delivery Program Lead is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.
The Associate Director Clinical Delivery Program Lead is responsible for the planning and delivery of the exploratory and biopharmaceutics clinical molecule and submissions milestones on time and on budget throughout the molecule lifecycle, as well as being responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact from trial design through execution and close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management.
Dependent on the operational/resource model chosen and influenced by the needs of the clinical development program, the Associate Director may be assigned additional trial level management support from internal or external resources. The will seek knowledge from internal and external sources and use this information to shape development plans and 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.
Stay informed & familiar with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.
Maintain knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions e.g. FHD requirements, detail of operations to deliver critical path 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 (if appropriate) 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 including initiation and management of the change process.
Proactively identify and communicate clinical risk assessments 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 to ensure on time and on budget clinical project deliverables.
Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward.
Partner with regulatory and medical to ensure safety management and monitoring processes are implemented.
Communication and Team Management:
Influence and work with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.
Manage key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).
Effectively and reliably communicate and influence at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders.
Leadership:
Collaborate effectively with colleagues at all levels; able to work with, and deliver, through others.
Skilled at working through ambiguity and effective problem-solving/solution-oriented skills to help develop and evaluate molecule level strategies from lead to legacy.
Successful in persuasion, influence, and negotiation skills in a matrix environment.
Foster spirit of learning agility, strategic thinking and the ability to think differently to incorporate new learning.
Contribute to the development of others by being an active source of constructive coaching and feedback to co-workers.
Minimum Qualification Requirements:
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).
Other Information/Additional Preferences:
Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
Advanced scientific degree.
Strong leadership and networking skills.
Early Phase (Phase 1) experience preferred.
Vendor management and contracting experience.
Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates).
Ability to influence and oversee TPOs to enable delivery of trial level deliverables.
Demonstrated knowledge and experience with project management tools and processes.
Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.
Excellent oral and written communication skills; able to communicate clearly and with team members and leadership.
Ability to travel (up to 10% expected).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
#WeAreLilly
#J-18808-Ljbffr