Clinical Operations Lead

Hiring Manager: Chief Medical Officer
Date Opened: February 2019

Position Summary:

The Clinical Operations Lead (COL) is responsible for execution of the clinical development plan for the assigned development programs. The successful candidate will work closely with the Program/Clinical Leader on all aspects of program oversight and management. The position requires excellent leadership, deep experience in drug development and networking capabilities to maximize the use of external resources (CRO’s, KOL’s, consultants etc.) and to integrate with internal domain expertise.

Roles & Responsibilities:

  • Manage 2 to 3 clinical programs at late preclinical, phase 1 or phase 2 stages of development

  • Operational clinical trial planning and execution according to study objectives, timelines and budget

  • Ensure GCP compliance and consistency in global trial execution

  • Management of study budgets, including Task Orders, Change Orders, expense accruals, invoice approval, and financial reconciliation

  • Work with line function leads to ensure all clinical and non-clinical deliverables are in place or scheduled to support clinical development plan; e.g. CMC, toxicology, DMPK, regulatory affairs, biostatistics, and data management

  • Provide operational leadership into clinical development strategy discussions; assess feasibility of operationalizing various strategic options

  • In conjunction with Clinical Leader, formulate and execute a cross-functional development plan that includes identifying key milestones and establishing program budget

Qualifications:

  • Master’s degree or equivalent education, preferably in a science or health related discipline

  • At least 10 years hands-on experience in clinical trials management or clinical research in biotech/pharma industry

  • Demonstrated success in clinical development, particularly in Phase 1 and/or 2 clinical trials across multiple therapeutic areas

  • Direct experience in multiple therapeutic areas, but particularly in the areas of immunology, oncology, infectious disease, gastroenterology, and dermatology, is desired

  • Strong project management skills and general understanding of project management tools, e.g. MS Project Gantt charts

  • Extensive experience in the selection and oversight of clinical CRO’s

  • Ability to perform in fast-paced, dynamic, constantly evolving environment

  • Excellent communication and organizational skills and attention to detail

  • Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals