Associate Director - Clinical Development (Oncology)
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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 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.
Purpose The Clinical Development Associate Director is responsible for executing integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team. This will be achieved through clinical development expertise and effective partnership with the Clinical Development Senior Director/Executive Director, Asset Team and Design Hub. The AD will lead the asset/indication clinical team who are responsible for the execution and delivery of the clinical package. They will also provide direction, leadership and technical/process expertise to their staff. In partnership with Clinical Development Senior Director/Executive Director they also will model and reinforce the leadership behaviors and ensure career development of staff.
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.
Clinical Planning
Responsible forclinicaldevelopment of theassigned compoundand/orindicationfrom asset strategy through submission, inspection,approvaland post-launch support.
Collaborates withtheClinicalDevelopment Senior Director/Executive Director, AssetTeamand Design Hub toaccelerate execution ofthe complete trial package (scope, timeline,budgetand risk management).
Leadthe globalclinicalsubmission strategy, including scope, timeline,resourceand risk management.
Clinical Execution
Ensures collaboration with Design Hub andCDTLand othercross-functional MDU team members for effective transitionof clinical trial packageto executionand clinical delivery.
Responsiblefor execution and delivery of the globalclinicalsubmission plan, including communications to team and leadership,resourceand risk management.
Responsible for executingclinicalplan/trial to the approved timeline; ability to understandthe criticalchainmethodologyanduse itsfunctionalityto manage program/trial; ability to makeupdates tothecriticalchainin PRISM.
Managesrisksplansat theindication/trial-levelduring the implementation in response to new data and changes in the environment.
Responsible for budget planning,monitoringand control of thetotal trialbudget at the indication-level; works closely with theCDTLs whoare responsible forthe trial-levelgrants andnongrantsbudgets and rolls-up budget informationtoClinicalDevelopment Senior Director/Executive Directorwho is accountable for thetotalclinical plan budget.
Responsible for completing theclinicalassumptionswithin the UAT (unified assumptions tracker), attending PFA/PSE meetings, and ensuring that the total trial budgets areaccurate.
Manages global cross-functionalcommunicationandescalations to ensure alignment on delivery and execution.
Utilizes regulatory and process knowledge to drive decision making.
Establishing and managing partner expectations,performanceand delivery (i.e.CRO, Alliances and Joint Ventures).
Effective Management
Aligncross-functional resources based on portfolioprioritizationinclusive of being flexible across therapeutic areas.
EnsureStudy ManagerCompetencies evolve and address implications to overall resource management and strategies.
Maintains a state ofinspectionreadiness forclinicaldevelopmentinclusive of TMF.
Modelsjudgement-based decision-making to navigate compliance and quality requirements.
Responsible for continuous improvement in the following:clinicaldevelopment, complete trial packages from the design hub and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conductingclinicaltrialsand non-trial work.
People Management
Recruit, develop andretainadiverse and highly capable workforce
Build an organizational culture that fostersinclusion
Support and encourage talentidentification, development and retentionthat reflects anend-to-endprocess mindset anddemonstratesjudgement-baseddecision making.
Ensure robusttraining plan andtimelycompletion of requiredtraining for direct reports.
Basic Requirements
Bachelor'sdegree, preferably in a scientific or health-related field
Minimum of 5years' experiencein the pharmaceutical industry and/orclinicaldevelopment
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Other Information/Additional Preferences:
Must understandclinicaldevelopment processes and the interdependencies of various tasks that require coordination among asset team, design hub, functional/regional team members and third parties
Demonstrated core project management skills through management ofcomplex/cross-functional projects, and/orclinicaltrials with a strong knowledge of regulations and guidelines
Strongcommunicationskills; able to communicateclearly and succinctly with team members and leadership
Must be capable of managing staff virtually and across geographies/cultures
Proven ability to coach and develop others
Ability to embrace the diversity of thought to modelinnovativebehaviors (e.g., reaching across boundaries, inspire and empower others and lead decisivelyin the midst ofambiguity)
Project Management certification (e.g., PMP)
Previoussupervisory experience strongly preferred
Prior experience in working with a non-Lilly business partner (e.g., CRO, Alliance, Joint Venture)
Prior submission and inspection experience
Prior experience with the management of business plans
Strong self-management and organizational skills; able to manage workload,set personal and teamprioritiesand adjust as needed
Able to influence others without direct authority
Strong problem-solving skills; able toanticipateand recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
Travel mayberequired
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
#J-18808-Ljbffr
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.
Purpose The Clinical Development Associate Director is responsible for executing integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team. This will be achieved through clinical development expertise and effective partnership with the Clinical Development Senior Director/Executive Director, Asset Team and Design Hub. The AD will lead the asset/indication clinical team who are responsible for the execution and delivery of the clinical package. They will also provide direction, leadership and technical/process expertise to their staff. In partnership with Clinical Development Senior Director/Executive Director they also will model and reinforce the leadership behaviors and ensure career development of staff.
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.
Clinical Planning
Responsible forclinicaldevelopment of theassigned compoundand/orindicationfrom asset strategy through submission, inspection,approvaland post-launch support.
Collaborates withtheClinicalDevelopment Senior Director/Executive Director, AssetTeamand Design Hub toaccelerate execution ofthe complete trial package (scope, timeline,budgetand risk management).
Leadthe globalclinicalsubmission strategy, including scope, timeline,resourceand risk management.
Clinical Execution
Ensures collaboration with Design Hub andCDTLand othercross-functional MDU team members for effective transitionof clinical trial packageto executionand clinical delivery.
Responsiblefor execution and delivery of the globalclinicalsubmission plan, including communications to team and leadership,resourceand risk management.
Responsible for executingclinicalplan/trial to the approved timeline; ability to understandthe criticalchainmethodologyanduse itsfunctionalityto manage program/trial; ability to makeupdates tothecriticalchainin PRISM.
Managesrisksplansat theindication/trial-levelduring the implementation in response to new data and changes in the environment.
Responsible for budget planning,monitoringand control of thetotal trialbudget at the indication-level; works closely with theCDTLs whoare responsible forthe trial-levelgrants andnongrantsbudgets and rolls-up budget informationtoClinicalDevelopment Senior Director/Executive Directorwho is accountable for thetotalclinical plan budget.
Responsible for completing theclinicalassumptionswithin the UAT (unified assumptions tracker), attending PFA/PSE meetings, and ensuring that the total trial budgets areaccurate.
Manages global cross-functionalcommunicationandescalations to ensure alignment on delivery and execution.
Utilizes regulatory and process knowledge to drive decision making.
Establishing and managing partner expectations,performanceand delivery (i.e.CRO, Alliances and Joint Ventures).
Effective Management
Aligncross-functional resources based on portfolioprioritizationinclusive of being flexible across therapeutic areas.
EnsureStudy ManagerCompetencies evolve and address implications to overall resource management and strategies.
Maintains a state ofinspectionreadiness forclinicaldevelopmentinclusive of TMF.
Modelsjudgement-based decision-making to navigate compliance and quality requirements.
Responsible for continuous improvement in the following:clinicaldevelopment, complete trial packages from the design hub and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conductingclinicaltrialsand non-trial work.
People Management
Recruit, develop andretainadiverse and highly capable workforce
Build an organizational culture that fostersinclusion
Support and encourage talentidentification, development and retentionthat reflects anend-to-endprocess mindset anddemonstratesjudgement-baseddecision making.
Ensure robusttraining plan andtimelycompletion of requiredtraining for direct reports.
Basic Requirements
Bachelor'sdegree, preferably in a scientific or health-related field
Minimum of 5years' experiencein the pharmaceutical industry and/orclinicaldevelopment
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Other Information/Additional Preferences:
Must understandclinicaldevelopment processes and the interdependencies of various tasks that require coordination among asset team, design hub, functional/regional team members and third parties
Demonstrated core project management skills through management ofcomplex/cross-functional projects, and/orclinicaltrials with a strong knowledge of regulations and guidelines
Strongcommunicationskills; able to communicateclearly and succinctly with team members and leadership
Must be capable of managing staff virtually and across geographies/cultures
Proven ability to coach and develop others
Ability to embrace the diversity of thought to modelinnovativebehaviors (e.g., reaching across boundaries, inspire and empower others and lead decisivelyin the midst ofambiguity)
Project Management certification (e.g., PMP)
Previoussupervisory experience strongly preferred
Prior experience in working with a non-Lilly business partner (e.g., CRO, Alliance, Joint Venture)
Prior submission and inspection experience
Prior experience with the management of business plans
Strong self-management and organizational skills; able to manage workload,set personal and teamprioritiesand adjust as needed
Able to influence others without direct authority
Strong problem-solving skills; able toanticipateand recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
Travel mayberequired
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
#J-18808-Ljbffr