The Upstream Bioprocess Scientist – TS/MS will be responsible for providing technical support for the introduction of manufacturing processes into the upstream operations/manufacturing environment in Limerick through the startup and into routine manufacturing operations. The successful applicant will have technical expertise in upstream bioprocessing and experience in data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and process improvements. They will maximize the benefits of a digital plant to gain in depth knowledge of the process through data analytics and process analytical technology. Key Responsibilities Knowledgeable of the science of upstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes Understand purpose and capability of each upstream unit operation and the impact of equipment on the process Provide technical support to the online process support team for process science, operational excellence and compliance Work as part of a cross-functional team at the interface between quality assurance, operations and engineering to bring deep technical expertise and scientific rigor to the team Utilize process monitoring tools to make data driven decisions to ensure process consistency and robustness Understand basic statistical methodologies engage with statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentation Identify process improvements and participate in implementation of Lean Manufacturing initiatives Generate scientific reports and technical documentation Understand and ensure compliance with safety, compliance, and regulatory expectations Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies Attributes for the Role Demonstrated technical capability with high productivity Proven track record of curiosity with learning agility Self-starter with high initiative and data-driven approach to problem-solving Demonstrated strong interpersonal skills Demonstrated strong verbal and written communication skills Demonstrated adaptability and flexibility to working in different environments, teams etc. Demonstrated ability to participate in and facilitate decision-making Educational Requirements BSc or MSc in Biochemistry, Biology, Biotechnology, Chemical Engineering or related discipline with relevant experience (>2 years’ experience within the biopharmaceutical industry) Work Environment These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise. 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. #WeAreLillyUKandIreland #J-18808-Ljbffr
Overview 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 Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. Purpose The Clinical Development Trial Lead (CDTL) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables. Primary Responsibilities This job description provides 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. Trial Leadership and Regional Operational Knowledge Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials. Scope: Understand the scope of work required to complete the clinical trial successfully. Monitor status and make changes per change control to meet deliverables. Timeline: Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies. Risk: Assess, identify and monitor trial-level risks. Create an integrated trial-level risk mitigation and contingency plan. Budget: Understand cross-functional, trial-level budget components. Create and monitor grants and non-grants, and assumptions using financial tracking tools. Network with appropriate business partners on budget status and changes. Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/Affiliate Study Training (ASTs)/Investigator Engagement Meetings. Drive and coordinate local, regional and global cross-functional study teams through study implementation, execution and closure, enabling them to meet deliverables, including issue management, contingency planning and resolution. Be accountable for trial/regional enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET). Partner with the Investigator Engagement organization to achieve regional enrollment goals. Manage relationships and serve as a single point of contact for trial communication to and from the Clinical Design and Delivery organization, cross-functional team members, and Third Party Organizations (TPOs). Apply problem-solving skills to daily issues with cross-functional study teams (including vendors, affiliates/regions, global team members, and other partners). Identify and assist in developing continuous improvement activities based on industry, regulatory, and new technology trends. Manage TPO qualification, selection, and oversight. Clinical Trial Process Leadership and Expertise Demonstrate understanding of the drug development process and the inter-relatedness of cross-functional activities; identify opportunities to deepen clinical trial process expertise. Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input for study teams. Serve as single point of accountability for the Trial Master File, ensuring the file is current and inspection-ready at all times. Anticipate trial and regional issues, identify process breakdowns, assess situations and propose proactive approaches to mitigate risks affecting delivery. Demonstrate ability to lead and influence amid ambiguity. Coach peers, cross-functional team members and TPOs on clinical trial processes and regional specifics. Apply knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards; liaise with affiliates to understand local regulatory requirements. Scientific Expertise Provide technical consultation for clinical and regulatory documents; prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates. Combine scientific knowledge with clinical trial operations to impact trial design, feasibility, implementation, and execution. Use clinical development knowledge and problem-solving to support scientific needs of the business and clinical programs. Minimum Qualification Requirements Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree. Highly Desired Skills Applied knowledge of trial execution methodology, processes, and tools Demonstrated ability to work cross-culturally with global colleagues and with TPOs Ability to influence without authority Strong leadership and networking skills in cross-functional and cross-cultural teams Effective communication, self-management, and organizational skills Problem-solving, critical thinking, and ability to navigate ambiguity Flexibility to adjust to altered priorities Other Information/Additional Preferences Need to travel periodically to AST/ISST/Investigator Engagement meetings and potentially other scientific or regional symposiums. Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 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 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 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. #WeAreLillyUKandIreland #J-18808-Ljbffr
Eli Lilly and Company in Cork is seeking a Clinical Development Trial Lead (CDTL) Associate to lead clinical trials with a focus on quality and on-time delivery. The role requires at least a bachelor’s degree and three years of clinical research experience. The ideal candidate will demonstrate strong leadership, effective communication skills, and the ability to work cross-culturally. The position offers opportunities for professional growth and requires periodic travel for meetings and symposiums. #J-18808-Ljbffr
Senior Associate/Manager - Clinical Trial Project Management, Exploratory Medicine page is loaded## Senior Associate/Manager - Clinical Trial Project Management, Exploratory Medicinelocations: Ireland, Corktime type: Full timeposted on: Posted Todayjob requisition id: R-104930At 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.****Overview:**The Clinical Trial Project Manager (CTPM) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CTPM Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.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.**Project Management, and Regional Operational Knowledge*** Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below: + Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial. + Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. + Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan. + Budget - Understand the cross-functional, trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes + Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs). + Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution. + Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET) + Partner with Regional Operatioins to achieve regional enrollment goals. + Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the CPM Organization, Regional Clinical Operations, and Third Party Organization (TPOs). + Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners). + Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. + Manage TPO qualification process, selection, and oversight.**Clinical Trial Process Leadership and Expertise*** Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.* Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.* Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time.* Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.* Demonstrate ability to lead and influence in the midst of ambiguity.* Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.* Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.* Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.**Scientific Expertise*** Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.* Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.* Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.**Minimum Qualification Requirements:*** Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.**Highly Desired Skills:*** Applied knowledge of project management methodology, processes and tools* #J-18808-Ljbffr
Eli Lilly and Company is seeking a Senior Associate/Manager for Clinical Trial Project Management in Cork, Ireland. This role involves leading cross-functional teams to develop and execute clinical trials, ensuring quality, and managing timelines and budgets. Candidates should have at least 3 years of clinical research experience and a Bachelor's degree in a scientific or health-related field. The benefits include a hybrid work model, healthcare, and various social initiatives. #J-18808-Ljbffr
Eli Lilly and Company seeks a Trial Capabilities Associate/Sr Associate to manage clinical trial budgets and contracts. This role involves negotiating with sites, ensuring compliance with local regulations, and managing financial data from partners. The ideal candidate holds a Bachelor's degree preferably in a related field with two years of clinical research experience. Effective communication and negotiation skills are essential. Join Eli Lilly to contribute to innovative clinical developments in a supportive environment. #J-18808-Ljbffr
Purpose The Trial Capabilities Associate/Sr Associate, Budgets & Contracts provides clinical trial capabilities in support of clinical development. The Associate, Budgets & Contracts is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials from budgets and contracts perspective and support ongoing budgets and contracts activities during site maintenance and close-out. The Associate, Budgets & Contracts is responsible for execution of the budget and contract, and activities related to clinical finance and records management. The Associate, Budgets & Contracts will ensure inspection readiness through contribution to a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. 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. Clinical Trial Responsibilities Initiate investigator site activities, including communicate and negotiate budgets and contracts with site personnel, service providers and internal teams, negotiate and obtain fully‑executed contract, and effectively drive timelines aligned with company priorities Responsible for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility Responsible for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards Communicate directly with sites to enable start‑up and maintain an active collaboration with sites regarding budgets and contracts activities during maintenance and close‑out Identify, communicate, and resolve issues related to budgets and contracts Ensure country specific regulatory and data privacy requirements are incorporated into budget and contract documents and any other documents/systems Leverage previous site / review board engagements to efficiently drive new work Populate internal systems to ensure accuracy of trial / site performance Understand and comply with procurements, legal and financial requirements and procedures Populate relevant Trial Master Files and libraries for future reference Provide feedback and shared learning for continuous improvement Leverage trial prioritization Anticipate and monitor dynamically changing priorities Clinical Finance Responsibilities Collect and administer financial data from contracting partners and vendors Ensure finance specific requirements are administered in budget and contract documents Ensure internal financial requirements are communicated to contracting partners and vendors Ensure contracting partner and vendor financial requirements are communicated to internally Support contracting partners, vendors and internal stakeholders during the payment process Identify, communicate, and resolve issues related to payments Minimum Qualification Requirements Bachelor’s degree preferably in a scientific, health related, engineering, economics or project management field, two years clinical research experience (CRO, sponsor or healthcare service provider) or relevant budget and contract negotiation experience preferred Understanding of the overall clinical development paradigm and the importance of efficient site activation Applied knowledge of project management processes and skills preferred Appreciation of / experience in compliance‑driven environment Ability to learn and comply with financial and legal guidelines and policies (budget and contract) Effective communication, negotiation, and problem solving skills Self‑management and organizational skills Language Capabilities (English and another European language) 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 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. #J-18808-Ljbffr
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. Organization Overview: Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction. Responsibilities: Senior Laboratory Analyst (Sr. Specialist - Analytical) key responsibilities shall include but shall not be limited to: Executing analytical procedures in accordance with current corporate specifications and cGMP’s and for maintaining the relevant SOP’s. Building / Maintaining QCL digital systems in collaboration with site and external Digital teams. Reporting results into a computer storage system (LIMS), as well as performing testing using automated systems. Involved in the qualification of analytical instruments and in their routine maintenance. Development, validation and verification of new methodologies, as part of new product introductions or process improvement activities. Recognizing atypical assay behavior and normally encountered equipment failure. Involved in deviation investigations and will record any errors encountered, as per procedures and training. Following all relevant Environmental, Health and Safety procedures and involved in incident investigations as required.Responsible for the maintenance of an inventory of chemicals and supplies used to perform analytical testing. Assisting in the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel. Responsible for adhering to, and improving, where appropriate, safety procedures to protect their other personnel and company property. Displaying a high level of integrity in the performance of their work. Relating well to other people with whom they come in contact, both within and outside of the laboratory area. Knowledgeable of general scientific methods and capable of learning and executing new techniques and instrumentation after appropriate training. May also be requested to partake in or lead area or cross-functional continuous improvement projects e.g. Six Sigma or other appropriate methodology. Basic Requirements: Hons BSc in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3 years pharmaceutical experience. Comprehensive knowledge of quality control operations with an emphasis on techniques such as immunoassays, quantitative PCR, chromatography, capillary electrophoresis and spectroscopy. Proficiency in the use of multiple instrument platforms (e.g. Agilent, Beckman Coulter,Sciex, Molecular Devices, Applied Bioscience, etc.) and associated software applications (e.g. SoftMax Pro, Empower, Accuseq LIMS / LES systems) Additional Skills/Preferences: Excellent attention to detail in all aspects of the work. Demonstrated understanding of Data Integrity and its application in a Digital Laboratory. Highly competent with computer systems. Experience working in cross functional teams and proven ability in decision making. Demonstrated ability in critical thinking, data analysis, problem solving and experience in root cause analysis. Strong organizational skills, including ability to follow assignments through to completion. Self-motivated, positive and ability to work under pressure. Demonstrates flexibility and adaptability to meet business needs. Excellent interpersonal and communication skills (written and oral). Demonstrates a continuous improvement mind-set. Demonstrated initiative – able to work proactively without direct supervision. Demonstrated ability to implement changes in technology and business systems / processes. Additional Information: Candidates must be able to travel for familiarization and training as required. May be required to work on a shift basis depending on production support needs. This can be further discussed at interview stage Candidates must meet the minimum qualifications outlined in the Educational Requirements section. 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. #J-18808-Ljbffr
Eli Lilly and Company is seeking a Senior Laboratory Analyst in Limerick. The role involves executing analytical procedures, developing methodologies, and maintaining quality control operations. Candidates should have an Hons BSc in Analytical Sciences and at least 3 years of pharmaceutical experience. Proficiency in various analytical instruments is essential. The company offers opportunities for training, advancement, and a collaborative working environment that prioritizes integrity and continuous improvement. #J-18808-Ljbffr
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!**Note:** Current openings is a fixed term opportunity in the therapeutic areas of Oncology**Organization Overview:**At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.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.**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**Additional Preference:*** Demonstrated technical and process expertise in clinical trial development. Must understand #J-18808-Ljbffr
