Clinical Development Senior Manager
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 39,000 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 make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 800 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 44 nationalities, speaking over 27 languages.
Established in 2010 to gain efficiencies in areas such as General Accounting, Purchase to Pay and Order to Cash, the GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions including Customer Meeting Services, Global HR Data Management, Medical Information, Procurement, Trail Capabilities, Global Scientific Communications and more to come on stream across 2020.
This, along with the physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story! Mirroring the existing Island House building, the new Island Hall facility extends our overall capacity to in excess of 1000 employees where Lilly will continue to offer a premium workspace across both buildings, complete with healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, barista, gym, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more.
At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations. We view the development of our highly skilled workforce in much the same way and want to grow your role into an empowering and fulfilling career here at Lilly. Therefore, with the sole purpose of employee progression, weekly Manager 1:1s, a dedicated Learning & Development service and Educational Assistance schemes all await you.
Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food.
TheClinical Development Senior Manager (CDM)is responsible for the recruitment, retention andresource assignment of theConsultants,Associates,andAssistants(study managers)managing trials in theClinical Development(CD)organization.The CDM provides leadership,direction,andtechnical/ process expertise to thestudy managers. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives ClinicalDesign,Delivery,&Analytics (CDDA)team collaboration to the achievement of goals and objectives. The CDM leads the clinical teamsresponsible for the execution and delivery of the clinical package. The CDMsupportsexecutionof theintegrated 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 andbroader Clinical Design, Delivery, & Analytics functions.
Recruit, develop, and retain a diverse and highly capable workforce
Ensure robustindividualtraining plans and timely completion of required training for direct reports.
Support andenabletalent identificationand careerdevelopmentthat reflects an end-to-end mindset and demonstrates judgement-based decision making.
Ensurestudy managercompetencies are present and continuously improving.
Managestudy managerworkload based on portfolioprioritization,regionalrequirements,and individuallevel of expertise,andaddress 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 developmentandmodelsinclusivity to ensure diverse voices and ideas are heard and considered
Serves as mentor for study managersand others in the CDDA.
As applicable,supportclinical development of assignedasset(s)from strategyand profile developmentthrough submission, inspection, approval and post-launch support.
Demonstrate strong business acumen, problem-solving skills, andlearningagility to help teamsplan for contingencies, and adjust to change.
Manage program-level activities including management of risk plansand oversight of budget planning, monitoring, and control, andsupports the accountabilitiesof theCDA
Works closely with the CTPMsto ensure efficientand on-timeexecution oftrials and enables aggregation / roll-up of keytrial metrics to track the status of the portfolio.
Understands and appliescore project management capabilities, includingimpact chain methodology and usage ofits functionality to manage program/trial
Partners across the CDDA to ensureeffective transition ofthe completeclinical trial package(scope, timeline, budget and risk management)throughtrialexecution and clinical delivery.
Manage global cross-functional communication andissueescalations to ensure alignment on delivery and execution.
Utilizeregulatory and process knowledge to drive decision-making
Establishesand managesexpectations of externalpartnerrelationships, performance and delivery(i.e. CRO, Alliances and Joint Ventures).
Align 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 byCDpersonnel.
Modelsjudgement-based decision making to navigate compliance and quality requirements
Responsible for continuous improvementand shared learningin thefollowing clinicaldevelopmentareas:study development, start-up, delivery, maintenance, and close-outprocesses, and collaborates withprocess owners in the spirit of streamlining,efficiency,and effectiveness of conducting clinical trials and non-trial work.
BachelorsDegree, preferably in a scientific or health-related field
Previousexperience, at least 5 years in a lead role in the pharmaceutical industry and/or clinicaldevelopment
Must understand clinical development processes and the interdependencies of various tasks that require coordination amongcross-functionalteam members and third parties
Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines
Strong communication skills; able to communicate clearly 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 decisively in the midst of ambiguity)
Other Information/Additional Preferences:
Project Management certification (e.g., PMP)
Prior experience in working withexternalbusiness partners(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 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
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 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-3360.
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.
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