Associate Director Clinical Program Operations in Indianapolis

Job Description

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

 

Position : Associate Director Clinical Program Operations

Location : Indianapolis, Indiana

Job id: R-24922

 

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.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 purpose of the Clinical Project Manager (CPM) is to lead the creation and execution of the exploratory and biopharmaceutics clinical operational development plan at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.The CPM is responsible to plan and deliver phase-I molecule and submission clinical achievements on time and on budget throughout the molecule lifecycle. The CPM is responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact from trial design through execution and close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational results), patient recruitment and retention and budget management. Dependent on the operational/resource model chosen and influenced by the needs of the clinical development program the CPM may be assigned additional trial level management support from internal or external resources. The CPM will seek knowledge from internal and external sources and use this information to shape development plans and seek opportunities for improvement.Primary Responsibilities:Scientific and Therapeutic Area ExpertiseProvides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications and manuscripts.Stays up-to-date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and standard methodologies.Maintains knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions e.g. FHD requirements, detail of operations to deliver critical path studies and submissions.Clinical Project Management:Leads and has expertise in the implementation and integration of clinical project management processes and tools.Works with Third Party Organizations (TPOs) to execute the defined clinical strategy, leading all aspects of key trial results.Develops and maintains up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team.Partners with the financial organization, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process.Proactively identifies and communicates clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates and leadership.Clinical Operations:Accountable and responsible for oversight of clinical trial operations and delivery of clinical project achievements on time, on budgetCreate and manage implementation timeline and clinical trial activitiesInvolved in selection process and management of vendors, providing day to day oversight for operational deliverables with external network of vendors to ensure on time and on budget clinical project deliverablesServes as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and communication across and upwardPartner with regulatory and medical to ensure safety management and monitoring processes are implementedCommunication and Team Management:Influences and works with quality approach across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.Manages key relationships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).Effectively and reliably communicates and influences at all levels across the organization clear and concise information to enable decision-making by team and governance/Partners.LeadershipCollaborates effectively with colleagues at all levels; able to work with, and deliver, through others.Skilled at working through ambiguity and effective problem-solving/solution oriented skills to help develop and evaluate molecule level strategies from lead to legacy.Successful in persuasion and influence in a matrix environment.Fosters spirit of learning agility, critical thinking and the ability to think differently to incorporate new learningContributes to the development of others by being an active source of constructive coaching and feedback to co-workers.People Management and Employee Development:Attract, retain and develop a diverse workforce.Model behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally.Seek opportunities to reward and recognize individuals and teams.Provide supportive environment for staff to explore innovative solutions to business problems and implement strategic and tactical decisions.Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed.Coach and mentor department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members.Basic Qualification:Bachelor’s degree3 years’ of direct experience of managing clinical studiesAdditional Preferences:Advanced scientific degree5-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (Phase -I)Vendor management and contracting experience.Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.Strong self-management, organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.Strong leadership and networking skills.Demonstrated ability to work effectively cross-culturally and in a virtual work environment.Demonstrated knowledge and experience with project management tools and processes.Demonstrated problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team.Excellent oral and written communication skills; able to communicate clearly and with team members and leadershipAbility to influence and oversee TPOs to enable delivery of trial level deliverables.Proven experience of coaching and mentoring others.Ability to travel (up to 10% expected)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.

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).

 

 

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