Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.
We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.
Functions as the clinical study team leader responsible for planning and managing all operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.
Roles and Responsibilities of the Position*
Responsible for the preparation and finalization of project and study- related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
Responsible for the selection of investigators and study sites
Responsible for identifying and responding to site and study related issues and recommending corrective actions.
Oversee the coordination of the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
Coordinate and manage Investigational Product including overall accountability and reconciliation
Responsible for the preparation of study budgets and timelines
Determine and manage project timelines and vendor performance to meet departmental and corporate goals
Determine and manage study budget and payment process for all clinical trial vendors including investigative sites
Monitor and track clinical trial progress and provide status update reports
Evaluate and Manage all clinical trial vendors (e.g., IVRS, central labs, and IRB)
Responsible for selection of CRO study staff and coordinating training including documentation
Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
Lead the planning of investigator meetings and making presentations, as required
Lead the review of clinical data at the CRF, data listing, and report table levels
Represent Clinical Operations at the Project Team level for individual studies, as appropriate
Partner with other research and development groups to achieve deliverables
Participate in Site Initiation Visits (SIVs) as required
Co-Monitoring of regional sites for adherence to protocol and GCP as required
Travel as required to carry out responsibilities
Identify and escalate site, vendor and study related issues to supervisor, as appropriate
Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
Potentially manage and direct activities of Clinical Trial Managers and Clinical Research Associates and if required, perform performance appraisals
Perform other duties as assigned
Required Qualifications and Background
BA/BS in related field
Minimum 8 years clinical drug development experience
Oncology and/or Hematology experience required
Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
Experience in managing oncology clinical trials (international preferred)
Knowledge of FDA regulatory requirements and medical practice/techniques and terminology
Ability to work within a team, including leadership skills
Ability to organize and prioritize multiple tasks
Excellent communication and interpersonal skills
Attention to detail, organization, and problem-solving skills
Demonstrated ability to work well with other accomplished professionals within and across functions/teams
Strong communication skills both written and oral
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Professional demeanor and appearance and an excellent written and verbal communicator
Detail oriented and well organized
Good and thoughtful listener
Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
Proficient in Microsoft Office suite and applications
Physical Demands / Travel
The physical demands of this job are consistent with light office duties.
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 encountered by an employee while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform each role and responsibility 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 Oncology, Inc. 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.