Associate Director, Clinical Trial Program Lead

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 2000 employees across 60 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. Inhouse 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.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself.

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 to 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 and is 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:  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.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Scientific and Therapeutic Area Expertise

• 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.
• Stays up-to-date Be informed & familiar with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.
• Maintains 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:

• 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 deliverables. 
• 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 organisation, 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 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
• Serves 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:

• Influences and works 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.
• Manages key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).
• Effectively and reliably communicates and influences at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders

Leadership

• Collaborates 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.
• Fosters spirit of learning agility, strategic thinking and the ability to think differently to incorporate new learning
• Contributes to the development of others by being an active source of constructive coaching and feedback to co-workers.

People Management

• Recruit, develop, and retain a diverse and highly capable workforce 

• Ensure robust individual training plans and timely completion of required training for direct reports. 

• Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgment-based decision-making. 

• Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high-talent staff are appropriately rewarded and developed. 

• Model behaviors and establish an environment where performance and results are valued and where individuals are learning and growing developmentally. 

• Seek opportunities to reward and recognize individuals and teams. 

• Manage Team workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies. 

• Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development and models inclusivity to ensure diverse voices and ideas are heard and considered 

• Coach and mentor department personnel, and as needed, cross-functional members in order to affect the development and growth of all team members. 

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+ year 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.

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