Eli Lilly
Healthcare
AssociateDirector-ClinicalDevelopmentNeuroscience
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“Associate Director - Clinical Development Neuroscience at Eli Lilly. Skills: clinical development leadership, clinical trial management, team performance, cross-functional collaboration, regulatory compliance. Provides leadership and direction for consultants, associates and assistants supporting trials within the Clinical Development (CD) organization. Ensures a high performance team culture”
What You'll Achieve.
achievement of goals and objectives of clinical development; accomplish milestones to plan; trial enrollment targets; enhance productivity and quality; achieving specific project team goals
Industry & Context.
Facilitates problem-solving; risk assessments; risk management plans; resolution of clinical trial operational issues
Travel may be required, fixed term opportunity
What They're Looking For.
Must Have
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 or an advanced degree, Minimum of 5 years clinical trial experience with a working knowledge of the clinical research process
Nice to Have
Demonstrated technical and process expertise in clinical trial development, Must understand the drug development process and inter-dependencies of various tasks and functional groups, communication skills, Proven ability to coach others, people and leadership skills with demonstrated ability to influence and lead across clinical functions, interpersonal, teamwork, and negotiation skills, self-management and organizational skills, Must be capable of managing staff virtually and across-borders and cultures, demonstrating an understanding of cultural differences, Previous supervisory experience, Global clinical trial experience, Prior experience with the management of business plans, Demonstrated business skills including the ability to understand and facilitate planning processes across clinical functions
What You'll Do.
Provides leadership and direction for consultants
associates and assistants supporting trials within the Clinical Development (CD) organization
Ensures a high performance team culture
Enables asset strategy
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
Responsible for clinical operational oversight of regional/global study level deliverables including trial enrollment targets
Ensures compliance with regulations and clarity in implementation of the process
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
Collaborates with Medical Sourcing
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
Aligns 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
retains and develops top talent to ensure a high performing team culture
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
Oversees and provides direction in obtaining appropriate personnel involvement as compliance issues are identified which require further action or follow-up
Shared responsibility with training group to ensure that curriculum maps and training programs/courses are maintained appropriately for staff members
Ensures that team members adhere to and complete trainings related to GCPs
and clinical best practices
Evaluates CDTLs capabilities and behaviors
aids in directly coaching or identifies appropriate coaches for consultants
associates and assistants
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
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
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
Partners with other cross-functional leadership in identifying and facilitating resolution of clinical trial operational issues
Facilitates high-level discussions with vendors
Manages the Performance Management process for staff members by providing input in yearly objectives
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
How You'll Work.
Team & Collaboration
Drives cross-functional team collaboration to the achievement of goals and objectives; Partners with functional, cross-functional and team leadership; Collaborates with Medical Sourcing, Procurement, CPM, and compound Team Management; Works closely with the clinical project manager; Facilitates discussions within functional counterparts; Facilitates problem-solving, shared learning and decision-making across clinical functions; Ensures development and implementation of cross-functional risk management plans; Partners with other cross-functional leadership
Communication Scope
Communicates effectively up and down in an organization; maintains confidentiality with respect to strategic and personnel matters
Process & Methodology
clinical trial planning and execution, regional/global study level deliverables, trial enrollment targets, business plans, planning processes across clinical functions
Full Job Description
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
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