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.
Location: South San Francisco, CA or Indianapolis, IN or Stamford, CT or Remote
Associate Director/Director, Clinical Operations
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.
The Clinical Trial Manager / Senior Clinical Trial Manager will manage one (or more) clinical studies including leading the planning, organization, and coordination of all operational aspects of the clinical study from protocol development through database lock / study closure; ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs; Provide operational leadership on cross-functional study team(s) and performance and quality oversight of Contract Research Organization (CRO) teams and other vendors.
Roles and Responsibilities of the Position*
Provide operational leadership on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
Lead and manage the execution of clinical trials, drive to solutions across a multi-functional study team.
Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
Use performance metrics and quality indicators to drive study execution.
Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study.
Manage study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
Collaborate with vendors and other study team members regarding study specific issues; drive team through issue resolution.
Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
Partner with internal contracts management to ensure review, finalization, and escalation as needed of site contracts and budgets.
Plan site and country identification and selection in collaboration with internal partners.
As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight.
Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
Lead study meetings including presenting as a subject matter expert as needed, ensuring agenda and meeting minutes are generated and distributed as needed.
Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors.
Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.
Manage Investigator Meeting coordination and planning.
Lead and assist in training other Clinical Operations roles (e.g. CRAs).
In addition to all activities listed, Senior Clinical Trial Managers must be able to manage large, complex trials and/or manage multiple ongoing studies simultaneously with minimal oversight.
Required Qualifications and Background
BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level; 6+ years’ experience required for Senior Clinical Trial Manager level.
For oncology studies: Oncology and/or Hematology experience preferred; for clinical pharmacology studies: Clinical Pharmacology/Healthy Volunteer experience preferred
Experience in managing global clinical trials preferred.
Experience with managing clinical research budgets.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Experience with managing a multi-functional team, including leadership skills and driving deliverables.
Demonstrates analytical approach and anticipation of problems.
Identifies gaps and provides constructive feedback and solutions.
Follows issues to resolution and escalates as appropriate.
Ability to multi-task effectively and prioritize assignments from multiple sources.
Excellent organizational skills.
Strong communication skills, both written and oral; proficiency in English.
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Physical Demands / Travel
The physical demands of this job are consistent with light office duties. Up to 15% travel may be required.
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.