Associate Director Clinical Development Immunology in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate Director Clinical Development Immunology in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Associate Director Clinical Development Immunology

Location : Indianapolis, Indiana

Job id: R-26183

 

Job Details

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 35,000 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 people around the world.The Clinical Development Manager (CDM) is responsible for the recruitment, retention and resource assignment of the Consultants, Associates, and Assistants (study managers) managing trials in the Clinical Development (CD) organization. The CDM provides leadership, direction, and technical/ process expertise to the study managers. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives Clinical Design, Delivery, & Analytics (CDDA) team collaboration to the achievement of goals and objectives. The CDM leads the clinical teams responsible for the execution and delivery of the clinical package. The CDM supports execution of the integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team. To achieve this goal, the CDM uses their clinical development expertise and effectively partners with the Clinical Development Advisor (CDA), Asset Team and broader Clinical Design, Delivery, & Analytics functions.Primary ResponsibilitiesPeople ManagementRecruit, develop, and retain a diverse and highly capable workforceEnsure robust individual training plans and prompt completion of required training for staff.Support and enable talent identification and career development that reflects an end-to-end mentality and demonstrates judgement-based decision making.Ensure study manager competencies are present and continue to improve.Manage study manager 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 consideredServes as mentor for study managers and others in the CDDA.Clinical DeliveryAs applicable, support clinical development of assigned asset(s) from strategy and profile development through submission, inspection, approval and post-launch support.Demonstrate strong eye for business, problem-solving skills, and learning agility to help teams plan for contingencies, and adjust to change.Manage program-level activities including management of risk plans and oversight of budget planning, monitoring, and control, and supports the accountabilities of the CDAWorks closely with the CTPMs to ensure efficient and on-time execution of trials and enables aggregation / roll-up of key trial metrics to track the status of the portfolio.Understands and applies core project management capabilities, including impact chain methodology and usage of its functionality to manage program/trialPartners across the CDDA to ensure effective transition of the complete clinical trial package (scope, timeline, budget and risk management) through trial execution and clinical delivery.Manage global cross-functional communication and issue partner concerns to ensure alignment on delivery and execution.Utilize regulatory and process knowledge to drive decision-makingEstablishes and manages expectations of external partner relationships, performance and delivery (i.e. CRO, Alliances and Joint Ventures).Effective ManagementAlign CDDA resources based on portfolio prioritization while demonstrating flexibility across therapeutic areas.Ensure a compliance culture and state of inspection readiness of TMF records created, maintained and finalized by CD personnel.Models judgement-based decision making to navigate compliance and quality requirementsResponsible for ongoing improvement and shared learning in the following clinical development areas: study development, start-up, delivery, maintenance, and close-out processes, and collaborates with process owners in the spirit of streamlining, efficiency, and effectiveness of conducting clinical trials and non-trial work.Basic Qualifications :Bachelor’s Degree, preferably in a scientific or health-related fieldPrior supervision experience (at least 2 years)Previous experience in clinical developmentAdditional Skills/Preferences :Pharma or CRO experienceMust understand clinical development processes and the interdependencies of various tasks that require coordination among cross-functional team members and business partners.Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelinesPrior drug application submission and inspection experienceStrong communication skills; able to communicate clearly and succinctly with team members and leadershipMust be capable of managing staff virtually and across geographies/culturesProven ability to coach and develop others.Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)Project Management certification (e.g., PMP)Previous supervisory experiencePrior experience in working with external business partners (e.g., CRO, Alliance, Joint Venture)Prior experience with the management of business plansStrong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as neededAble to influence others without direct authorityAble to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrenceDemonstrated exemplary teamwork/interpersonal skillsDemonstrated strong problem solving, attention to detail and result oriented behaviors in a fast-paced environment.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). #WeAreLilly

 

 

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