As a Clinical Development Manager, you will provide direction, leadership, and technical/ process expertise to the consultants, associates, and assistants supporting trials within the Clinical Development (CD) Organization. You will lead the asset/indication clinical team responsible for the execution and delivery of the clinical package. It is critical that you are able to execute integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team. To achieve this goal, you will use your clinical development expertise and effectively partner with the Clinical Development Advisor, Asset Team and Design Hub. You will model and reinforce the leadership behaviors and ensure career development of staff in partnership with Clinical Development Advisors.
People management is an important aspect of any organization. In this role, you will work to recruit, develop, and retain a diverse and highly capable workforce. We desire to build an organizational culture that cultivates inclusion. You will support and encourage talent identification, development and retention that reflects an end to end process mindset and demonstrates judgement based decision-making. Ensuring robust training plans and timely completion of required training for direct reports will also be key. Additionally, you will:
- Ensure Study Manager competencies are present to execute and are continuously improving. This role is specifically responsible for the capabilities of Clinical Trial Project Managers (CTPMs) and Clinical Trial Project Management Assistants (CTPMAs).
- Manages CTPM/CTPMA workload based on portfolio, global requirements and expertise level of the individual.
- Encourages staff to utilize metrics data in order to assess the current program status program, to monitor progress, and to seek opportunities for improvement over time.
With respect to clinical trial planning, your will play a vital role in clinical development of your team’s assigned compound and/or indication from asset strategy through submission, inspection, approval and post-launch support. You will lead the global clinical submission strategy, including scope, timeline, resource, and risk management while collaborating with the Clinical Development Advisor, Asset Team and Design Hub to accelerate execution of the complete trial package
You will foster collaboration with the Design Hub, CTPM, and other cross-functional Medical Development Unit (MDU) team members for effective transition of clinical trial packages to through execution and clinical delivery. You will manage global cross-functional communication and escalations to ensure alignment on delivery and execution. Management of risks plans at the indication/trial-level during the implementation in response to new data and changes in the environment will be an important part of this role. Other activities include:
- Execution and delivery of the global clinical submission plan, including communications to team and leadership, resource and risk management
- Executing clinical plan/trial to the approved timeline; ability to understand the impact chain methodology and use its functionality to manage program/trial; ability to make updates to the impact chain.
- Responsibility for budget planning, monitoring and control of the budget at the indication-level; works closely with their CTPMs who are responsible for the trial-level budgets and rolls-up budget information to Clinical Development Advisor who is accountable for the clinical plan budget.
- Utilizing regulatory and process knowledge to drive decision-making
- Establishing and managing partner expectations, performance and delivery (i.e. CRO, Alliances and Joint Ventures)
You should draw from past experiences to align cross-functional resources based on portfolio prioritization while demonstrating flexibility across therapeutic areas. The ability to maintain a state of inspection readiness for clinical development inclusive of Trial Master File (TMF) is also highly important. You ability navigate compliance and quality requirements with effective discernment will be highly valuable. Additionally you will:
- Address implications to overall resource management and strategies
- Be responsible for continuous improvement in the following: clinical development, complete trial packages from the design hub and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work.
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.
- Bachelor Degree, preferably in a scientific or health-related field
- Minimum of 5 years experience in the pharmaceutical industry and/or clinical development
- 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.
- Travel may be required
- 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.
- Therapeutic knowledge in Diabetes, Oncology including early phase experience, Immunology, and Pain.
- Understanding of the clinical development processes and the interdependencies of various tasks that require coordination among asset team, design hub, functional/regional team members and third parties
- Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a good knowledge of regulations and guidelines
- Demonstrated ability to communicate clearly and succinctly with team members and leadership
- Ability to manage staff virtually and across geographies/cultures
- Proven ability to coach and develop others
- Ability to embrace diversity of thought to model innovate behaviors (e.g., reach across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
- Project Management certification (e.g., PMP)
- Previous supervisory experience
- Prior experience in working with business partner (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; 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