The Director, Clinical Operations will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Director, Clinical Operations will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Kiniksa SOPs. This role will work closely and collaboratively with Program Management, Clinical, Medical Writing, Biostatistics, CMC, Drug Safety and Regulatory staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget. Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company.
- Leads and directs the clinical operations team responsible for management and execution of all clinical trials. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met (depending on the program scope, the Senior Director may still have direct trial management responsibilities).
- Provides strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed.
- Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
- Collaborates with the appropriate functions in defining the outsourcing strategy for the development programs.
- Establishes the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.).
- Assists in the authoring of key regulatory documents (e.g., CTD, pre-meeting materials and briefing packages), study protocols, investigator’s brochures, annual IND progress reports, study postings, and CSR for consistency across programs.
- Develops in-depth knowledge of the clinical data and assures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence.
- Provides input to Program Management, in case of project prioritization exercises within the portfolio.
- Ensures that study objectives are in line with the clinical development strategy and the overall corporate goals.
- Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
- Supports the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
- Collaborates with KOLs for feedback on study protocols and development plans.
- Implements and leads a Clinical Development Team.
- Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
Education and Experience:
- Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree preferred.
- 10+ years of strong hands-on experience leading clinical trials execution, both in the USA and Europe.
- Minimum 3 years in supervisory role managing clinical operations staff.
- Ability to take a leadership role, motivate staff, and drive high quality execution.
- Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Effective communication and interpersonal skills; effective interaction with senior management.
- Flexibility to travel domestically and internationally as required.
- Superior project management skills and risk management skills.
- Pragmatism and ability to manage multiple projects and needs effectively.
- Positive outlook and ability to quickly assess and action complex needs.
- Excellent listening, communication (written, spoken) and interpersonal skills, fostering team spirit.
- Consistent delivery of high quality work at all times.
- Solid well-grounded experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas.
- Extensive experience managing CROs providing electronic data capture and data management, in addition to extensive experience working with drug safety service providers especially with respect to electronic transmission of data between the CROs.
- Extensive experience in delivering clinical study reports with complete appendices, CRFs and electronic datasets.
- Knowledge and experience in preparation of Clinical sections of INDs, CTAs, BLAs, MAAs and NDSs, including data needed for completion of sections in eCTD Module 1.
- Ability to accurately project budgets and manage them across studies and projects.
- Proficient in use of electronic clinical database software and other programs such as Microsoft Office.