Apply on Employer Site

Eli Lilly and Company · 20 hours ago

Associate Director-Clinical Development-Immunology

Indianapolis, IN

Full-time

Onsite

Lead/Staff, Director/Executive

$123K/yr - $180K/yr

5+ years exp

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, seeking an Associate Director of Clinical Development in Immunology. The role involves executing integrated clinical development plans and leading clinical teams to ensure the successful delivery of clinical trial packages.

BiotechnologyHealth CareMedicalPharmaceutical

No H1B

Responsibilities

Responsible for clinical development of the assigned compound and/or indication from asset strategy through submission, inspection, approval and post-launch support

Collaborates with the Senior Director/Executive Director Clinical Development, Asset Team and Clinical Design to accelerate execution of the complete trial package (scope, timeline, budget and risk management)

Lead the global clinical submission strategy, including scope, timeline, resource and risk management

Ensures collaboration with Clinical Design and Clinical Development Trial Lead (CDTL) and other cross-functional MDU team members for effective transition of clinical trial package to execution and clinical delivery

Responsible for execution and delivery of the global clinical submission plan, including communications to team and leadership, resource and risk management

Responsible for executing clinical plan/trial to the approved timeline; ability to understand the critical chain methodology and use its functionality to manage program/trial; ability to make updates to the critical chain

Manages risks plans at the indication/trial-level during the implementation in response to new data and changes in the environment

Responsible for budget planning, monitoring and control of the total trial budget at the compound and or indication-level; works closely with the CDTLs who are responsible for the trial-level grants and nongrants budgets and rolls-up budget information to Senior Director/Executive Director Clinical Development who is accountable for the total clinical plan budget

Responsible for completing the clinical assumptions within the UAT (unified assumptions tracker), attending financial meetings, and ensuring that the total trial budgets are accurate

Manages global cross-functional communication and escalations to ensure alignment on delivery and execution

Utilizes regulatory and process knowledge to drive decision making

Establishing and managing partner expectations, performance and delivery (i.e. CRO, Alliances and Joint Ventures)

Align cross-functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas

Ensure Clinical Development Trial Lead Competencies evolve and address implications to overall resource management and strategies

Maintains a state of inspection readiness for clinical development inclusive of the Trial Master File (TMF)

Models judgement-based decision-making to navigate compliance and quality requirements

Responsible for continuous improvement in the following: clinical development, complete trial packages from the Clinical Design and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work

Recruit, develop and retain a diverse and highly capable workforce

Build an organizational culture that fosters inclusion

Support and encourage talent identification, development and retention that reflects an end-to-end process mindset and demonstrates judgement-based decision making

Ensure robust training plan and timely completion of required training for direct reports

Qualification

Clinical development expertiseProject management experienceTeam managementBudget planningRegulatory knowledgeClinical trial executionCoachingDevelopmentSelf-managementInfluencing skillsDiversityInclusionProblem-solving skills

Required

Bachelor's degree, preferably in a scientific or health-related field

5+ years in the pharmaceutical industry and/or clinical development

5+ years project management experience across the clinical trial landscape

3+ years managing a team of direct reports virtually and across geographies/cultures

Experience managing clinical development processes and associate tasks

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Preferred

Project Management certification (e.g., PMP)

Previous supervisory experience

Proven ability to coach and develop others

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

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)

Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed

Able to influence others without direct authority

Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence

Travel may be required