Loxo@Lilly Process Improvement Manager (Contract) in Raleigh, North 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 Contract Process Improvement Manager is responsible for overseeing the project management activities of all assigned process improvement initiatives. This role ensures initiatives are appropriately tracked, resourced, and budgeted for successful completion, and ensures the project status is transparently disseminated throughout the organization. They maintain effective working relationships at all levels within and outside of Loxo@Lilly.
The ideal candidate will have deep experience within the field of project management/process improvement, as well as a sufficient degree of knowledge of clinical development activities, including clinical data management, clinical operations, data collection software, and GxP best practices. The individual will be a self-starter with excellent leadership skills, strong focus on innovation, collaboration, and most importantly, project management and process improvement methodology and tools.
*Roles and Responsibilities of the Position:
Facilitates the collection of lessons learned and the identification of process improvement opportunities
Develops and finalizes project charters, timelines, and costing for assigned initiatives
Establishes and leads brainstorming sessions, kick off meetings, and recurring project team meetings
Responsible for robust stakeholder management and the maintenance of the project’s timelines, risks, actions, issues, and decisions (RAID) log, and various dashboards, throughout the life of the project
Proactively identifies significant project risks, develops mitigation strategies, escalates to leadership, and implements approved mitigation steps
Supports planning and execution statuses in recurring project review meetings
Manages and maintains project scope through project completion
Sustains and grows industry knowledge with regards to innovations in trial execution best practices, clinical tools and technology, and information delivery to key stakeholders
Evaluates new software and technologies, as appropriate
Required Qualifications and Preferred Background:
Bachelor’s degree preferred.
Minimum of 5 years’ project management experience within pharmaceutical industry.
Demonstrated leadership and project management skills, preferably in clinical development
Project Management Professional (PMP) and/or Six Sigma certification is a strong plus
Thorough and broad knowledge of clinical development processes and tools preferred.
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
Must have excellent verbal, written and communication skills.
Ability to work independently as well as in a team environment.
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
Demonstrated ability to stay abreast of trends and new information in the profession.
Physical Demands/ Travel:
The physical demands of this job are consistent with light office duties. This position will travel rarely; the average travel for this position is less than 5% with some variation based upon the demands of the business imperatives.
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 a home-based office setting.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
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.