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.
At Eli Lilly Cork, 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 45,000 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 patients 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!

BASIC REQUIREMENTS:

• Bachelors or University degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.
• Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process

PURPOSE:

The Clinical Development Associate Director provides leadership and direction for the consultants, associates and assistants supporting trials within the Clinical Development (CD) organization and ensures a high performance team culture.
This position enables asset strategy, focuses on results, and emphasizes and drives cross-functional team collaboration to the achievement of goals and objectives of clinical development within the broader Clinical Design Delivery Analytics (CDDA) organization. Collaborates with the Clinical Development Advisor to ensure that trial-level planning and execution are in alignment with strategy and timelines.
The Manager is responsible for clinical operational oversight of regional/global study level deliverables including trial enrollment targets while ensuring compliance with regulations and clarity in implementation of the process.

RESPONSIBILITIES:

Business Planning

• Partners with functional, cross-functional and team leadership to provide operational input into the feasibility and resource requirements associated with clinical plans.
• Provides strategic direction and leadership to CTPMs to enable them to drive the implementation of the Regional/Global enrollment strategy, to accomplish milestones to plan. Escalates related issues to appropriate parties for awareness and resolution.
• Collaborates with Medical Sourcing, Procurement, CPM, and compound Team Management to provide and enable decisions related to internal/external-sourcing options.
• Works closely with the clinical project manager to ensure planning databases are accurate and up-to-date.

Resource Management

• Works to align resources based upon team prioritization decisions and regional participation in the trial.
• Manages study management personnel workload based on portfolio, global and regional requirements and expertise level of the individual.
• Facilitates discussions within functional counterparts to manage team priorities and address unplanned demands.
• Recruit, retain and develop top talent to ensure a high performing team culture.

Trial Management Expertise

• Facilitates problem-solving, shared learning and decision-making across clinical functions.
• Participates in risk assessments at the clinical plan level and ensures development and implementation of cross-functional risk management plans at the trial level.
• Ensures inspection readiness of respective study team(s). Oversees and coaches CDTLs in the timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high risk areas/hot topics).
• Oversees and provides direction in obtaining appropriate personnel involvement as compliance issues are identified which require further action or follow-up.

Training and Compliance

• Has shared responsibility with training group to ensure that curriculum maps and training programs/courses are maintained appropriately for staff members to enable them to perform their job responsibilities. Consults as appropriate on new training programs/courses.
• Ensures that team members adhere to and complete trainings related to GCPs, global SOPs, and clinical best practices.
• Evaluates CDTLs capabilities and behaviors, aids in directly coaching or identifies appropriate coaches for consultants, associates and assistants to enable them to become proficient in completion of study responsibilities.
• Monitors training compliance for consultants, associates and assistants ensuring timely completion of all required courses.
• Ensures quality in clinical research activities by promoting consistent use of GCPs, global SOPs, and best practices.

Application/Improvement of Processes

• Generates innovative ideas, leads and/or provides input into new processes and process improvements within the clinical organization to enhance productivity and quality.
• Actively supports staff to share any new learning opportunities or technologies within or across clinical functions.
• Encourages staff to utilize metrics data in order to assess the current status of the clinical program, to monitor progress, and to seek opportunities for improvement over time.
• Participates in reviewing and implementing new clinical trial processes within teams. Assesses the impact of these changes in achieving specific project team goals.

Communication

• Partners with other cross-functional leadership in identifying and facilitating resolution of clinical trial operational issues.
• Facilitates high-level discussions with vendors, as appropriate.

Performance Management

• Manages the Performance Management process for staff members by providing input in yearly objectives, reviewing progress, and providing timely and objective feedback and completing appropriate documentation.
• Completes salary administration for reporting staff members.
• Completes talent assessment and succession planning for direct reports, and discusses results with individual staff members maintaining the integrity and privacy of the data.