Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate Director, Clinical Program Operations – Early Phase in Bracknell, Apply Lilly careers in Bracknell .
Position : Associate Director, Clinical Program Operations – Early Phase
Location : Bracknell, United Kingdom
Job id: R-24920
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.Associate Director, Clinical Program Operations – Early PhaseBracknell, flex workingAbout Lilly:Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.About the Role:The Associate Director position is seen as a key source of information in the Early Phase group, spanning both project and programme management to deliver outstanding clinical trial operations. As an Associate Director within our Clinical Program Operations Early Phase group, you will lead the creation and execution of the exploratory and biopharmaceutics clinical operational development plan at a molecule level. This will give you the chance to use both technical leadership and operational skills for the management of clinical research trials within the development plan. The Clinical Program Operations team is a group heavily focused on scientific and technical excellence within Lilly and has a strong culture of collaboration and knowledge sharing.As an Associate Director you will work with a diverse group of functional experts to develop the strategy and deliver the phase-I plan on time and on budget. Your responsibility will span all aspects of global clinical trial operations, working as the single operational point of contact from trial design through execution and close out. Other elements you will be involved in include timeline creation and management, development of the outsourcing plan, vendor management (including direct oversight of the operational results), patient recruitment/retention and budget management. You will be responsible for managing and ensuring that key milestones are achieved throughout the early phase lifecycle of the molecule.Dependent on the needs of the clinical development program, you may be assigned additional trial level management support from internal or external resources.If you are a Project Manager/Senior Project Manager looking to expand your skills and work on World Class clinical development programmes within a market leading pharmaceutical organisation then the Associate Director, Clinical Program Operations – Early Phase role at Lilly is for you!Primary Responsibilities:Scientific and Therapeutic Area ExpertiseProvide 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.Stay up-to-date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and standard methodologies.Maintain knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissionsClinical Project Management:Lead with expertise on the implementation and integration of clinical project management processes and tools.Work with Third Party Organisations (TPOs) to execute the defined clinical strategy, leading all aspects of key trial results.Develop and maintain up-to-date clinical plan timelines and process mapsPartner with the financial organisation, 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 identify and communicate 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 deliverablesServe 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 implementedBasic Qualifications:Bachelor’s degreeAdvanced scientific degreeSeveral years of direct experience of project managing clinical studiesStrong knowledge of regulations and guidelines that apply to the conduct of clinical trialsStrong leadership and networking skillsAdditional Preferences:Exploratory and biopharmaceutics clinical development (Phase I)Vendor management experience.Strong self-management, organisational and interpersonal skills, and the ability to be flexible in varying environments and with multiple customer groups.Demonstrated ability to work effectively cross-culturally and in a virtual work environment.Demonstrated knowledge and experience with project management tools and processes.Ability to influence and oversee TPOs to enable delivery of trial level deliverables.Ability to travel (up to 10% expected)Bring your true self to workEmbracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.#LI-LD1Eli 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 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.
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