Loxo@Lilly Project Team Leader, Clinical Asset Operations (early development) in Columbia, South Carolina
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
The Project Team Leader, Clinical Asset Operations will drive implementation of drug development strategy for simple to complex assets, including a platform of moderate to complex assets. This individual will be accountable for the translation of the marketing, medical, manufacturing and regulatory needs for the molecule/new indication/line extension into a single global integrated plan. They will also lead the application and integration of key project management processes and tools across teams to deliver asset and portfolio value with quality, on time, on budget, and within scope, including performance of cross-functional/corporate processes (integrating with Loxo@Lilly processes and late-stage oncology, where appropriate), and alliance management (if applicable). In addition, they will be expected to effectively manage upward and cross-functional communication, anticipate and resolve issues with the team, and serve as a drug development expert within their team(s), as well as to the other Asset Operation Leaders.
Roles and Responsibilities of the Position:
Enable Strategy for Assigned Asset(s)
Lead the development of the molecule/platform strategy, leveraging quality decision making principles.
Accountable for ensuring alignment of strategy with the approved scope (indications, resources, etc.)
Accountable for obtaining alignment with Loxo Senior Leadership on the timing of and data package that will support Commercial Decision for the assigned asset
Accountable for obtaining alignment with Loxo Senior Leadership to determine appropriate transition timing for the assigned asset from early phase to late phase and ensuring appropriate transition plan in place
Lead the alignment between molecule/platform strategy and implementation.
Ensure there is a change management process in place on the team to manage scope.
Understand and incorporate the concepts of portfolio management, where appropriate, to the assigned molecule
Integrated plan development for Assigned Asset(s)
Lead creation of a global plan that articulates the strategy for the molecule/platform and provides the foundation for operational objectives (Clinical Plan, CM&C development Plan, Regulatory Plan, R&D Capacity Plan, Intellectual Property Plan, Commercial/PRA Plan and Publication Strategy/Plan).
Provide or drive immediate and accurate communication of key decisions/results that have team, asset, and/or organizational impact. Work with Loxo CEO, communications lead and Lilly Investor Relations to manage communication about the asset outside of the company.
Portfolio Alignment: Lead delivery of a plan that is in alignment with Loxo priorities and the approved molecule/indication scope.
Cost Management: Drive development of an integrated project budget always keeping a minimum of 8 quarters in planning horizon.
Risk Management: Owns risk management strategy and plan for the team.
Obtain required approvals for the molecule/platform plan.
Deliver Results for Assigned Asset(s)
Accountable for delivery of project milestones with quality, on time, on budget, and within scope.
Lead the team to meet or exceed overall project goals (completion of clinical studies, submission and approval timing, publications, etc.)
Accountable for delivery of high quality, timely, data driven decisions.
Accountable for ensuring that cost, timeline, scope, and risk management processes are in place on the team to monitor and control performance of the overall project that utilizes appropriate tools and techniques (Prism, budget: plan vs actual, change control, etc.).
Hold functions accountable for achievement of key project deliverables in alignment with the agreed to project plan and in compliance with Loxo quality standards.
Deliver cross-functional results through people utilizing project management, influence and communication skills rather than direct or positional authority.
Contribution to Project Management Excellence
Accountable for the implementation, application, and integration of standard project management processes and tools including but not limited to the development, monitor, and control of integrated scope, timelines, budgets, risk management plans, and communication plans to all assigned asset(s).
Accountable for ensuring project management tools and techniques and the data they generate are used to manage the assigned asset(s).
Key resource for shared learning, process improvement, and early-phase and late-phase integration
Drive retrospective project/process review meetings (i.e. after action reviews) to identify issues and strengths and help capture learning.
Mentor and coach others in the development of project management skills and knowledge in drug development/drug discovery.
Experts in integrated drug development, drug discovery and project management within and external to the department.
Be a leader in the AOL community and actively mentor/partner with your peers.
*Required Qualifications and Preferred Background:
Bachelor's Degree, preferably in a health-related, scientific or engineering field required.
10+ years of work experience in the pharmaceutical industry and/or drug development required.
Ideal candidate will also have:
Advanced graduate degree (PhD, MPH, PharmD, etc.)
Previous experience with or knowledge of drug development processes in oncology
Successful history of delivering drug development projects
Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership
Excellent problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team
Excellent self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed. Must be able to manage working with a large number of different teams with varying styles, issues, complexity.
Excellent interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback
Excellent leadership, interpersonal and influence skills; Ability to provide leadership to others, to appropriately network across a wide variety of functional components, external vendors/partners.
Excellent Business Acumen; Ability to leverage business principles within the team while maintaining a corporate view of the portfolio.
Flexibility to adjust quickly and effectively to frequent change and altered priorities.
Applied knowledge of project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk and procurement)
Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project
Practical experience performing project management for a cross-functional project
In depth understanding of the drug discovery and development process
Strong scientific background
Additional Location for this Role:
- This role can be based: Remotely or in Indianapolis, IN/South San Francisco, CA/Stamford, CT
Loxo@Lilly currently anticipates that the base salary for the Senior Director level position could range from between $144,000 to $211,200 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described.
The physical demands of this job are consistent with an office setting. Domestic Travel will be 10%.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is in an office
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Loxo@Lilly (Eli Lilly and Company) 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.
Loxo@Lilly (Eli Lilly and Company) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email email@example.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.