Careers

Careers at Loxo


We are highly committed to building a company that is focused on helping patients overcome cancer through creating highly selective therapies that target specific genetic alterations. We are looking for people who embrace innovation, challenge the status quo and believe in the power of precision medicine. Most importantly, we are looking for people who believe that they can make a real difference.

Loxo Oncology is seeking passionate, professionals to join our dedicated team determined to make a difference in the lives of patients with genetically defined cancers. Please review our current openings below by selecting the appropriate link to find out more about that opportunity.


Department:

Clinical Operations and Project Management

Location:

Stamford, CT

Reports To:

Associate Director Clinical Operations

Position Description:

Functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study 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.

Job Responsibilities (Key Responsibilities):

  • 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 and/or escalating to supervisor
  • Coordinate 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
  • Ensure that CRF data queries are resolved
  • Coordinate and manage Investigational Product including overall accountability and reconciliation
  • Responsible for the preparation of study budgets and timelines
  • Manage project timelines and vendor performance to meet departmental and corporate goals
  • 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
  • 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 with minimal supervision in 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
  • Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
  • Perform other duties as assigned

Job Qualifications:

  • Minimum 8 years clinical drug development experience
  • Experience in personnel management
  • 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
  • 25% travel required

Education and Skills:

  • BA/BS in related field
  • 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
  • Computer literate

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