Clinical Development Senior Manager

Eli Lilly and Company (Cork, Ireland) 27 days ago

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.

Job Description

  • At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 

    Path/Level: 

    M2

    Note: Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting.  For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.

    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. 

    Purpose: 

    The Clinical Development Senior Manager (CDM) is responsible for the recruitment, retention and resource assignment of the Consultants, Associates, and Assistants (study managers) managing trials in the Clinical Development (CD) organization. The CDM provides leadership, direction, and technical/ process expertise to the study managers. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives Clinical Design, Delivery, & Analytics (CDDA) team collaboration to the achievement of goals and objectives. The CDM leads the clinical teams responsible for the execution and delivery of the clinical package. The CDM supports execution of the integrated 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 and broader Clinical Design, Delivery, & Analytics functions.   

    Primary Responsibilities:  

    People Management 

    • Recruit, develop, and retain a diverse and highly capable workforce  

    • Ensure robust individual training plans and timely completion of required training for direct reports.   

    • Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making.    

    • Ensure study manager competencies are present and continuously improving.  

    • Manage study manager workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address 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 development and models inclusivity to ensure diverse voices and ideas are heard and considered 

    • Serves as mentor for study managers and others in the CDDA. 

    Clinical Delivery 

    • As applicable, support clinical development of assigned asset(s) from strategy and profile development through submission, inspection, approval and post-launch support.  

    • Demonstrate strong business acumen, problem-solving skills, and learning agility to help teams plan for contingencies, and adjust to change.

    • Manage program-level activities including management of risk plans and oversight of budget planning, monitoring, and control, and supports the accountabilities of the CDA  

    • Works closely with the CTPMs to ensure efficient and on-time execution of trials and enables aggregation / roll-up of key trial metrics to track the status of the portfolio. 

    • Understands and applies core project management capabilities, including impact chain methodology and usage of its functionality to manage program/trial 

    • Partners across the CDDA to ensure effective transition of the complete clinical trial package (scope, timeline, budget and risk management) through trial execution and clinical delivery.  

    • Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution.  

    • Utilize regulatory and process knowledge to drive decision-making 

    • Establishes and manages expectations of external partner relationships, performance and delivery (i.e. CRO, Alliances and Joint Ventures).  

    Effective Management 

    • 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 by CD personnel. 

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

    • Responsible for continuous improvement and shared learning in the following  clinical development areas: study development, start-up, delivery, maintenance, and close-out processes, and collaborates with process owners in the spirit of streamlining, efficiency, and effectiveness of conducting clinical trials and non-trial work.   

    Requirements: 

    • Bachelors Degree, preferably in a scientific or health-related field 

    • Previous experience, at least 5 years in a lead role  in the pharmaceutical industry and/or clinical development 

    • Must understand clinical development processes and the interdependencies of various tasks that require coordination among cross-functional team 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 model innovative behaviors (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 with external business 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 

    Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

    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.

    #WeAreLilly

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.

Clinical Development Senior Manager

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