Kiniksa Pharmaceutical Lexington , MA 02421
Posted 3 weeks ago
Reporting to the VP, Clinical Operations & Medical Writing the Sr. Director will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Sr. Director 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.
This role must be based our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Lead and direct 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 Sr. Director may still have direct trial management responsibilities)
Provide strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed
Develop and maintain 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
Collaborate with the appropriate functions in defining the outsourcing strategy for the development programs
Establish the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.)
Assist 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
Develop in-depth knowledge of the clinical data and assures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence
Provide input to Program Management, in case of project prioritization exercises within the portfolio
Ensure that study objectives are in line with the clinical development strategy and the overall corporate goals
Ensure external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation
Support 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
Collaborate with KOLs for feedback on study protocols and development plans
Foster a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders
Qualifications:
10+ years of strong hands-on experience leading clinical trials execution, both in the USA and Europe
Bachelor's degree in Life Sciences or Pharmacy required.
Advanced degree preferred
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
Solid well-grounded experience in setup, execution and operational management of US and global Phase 1, 2, and 3 clinical trials across an array of therapeutic areas; experience in cardiovascular, as well as in rare diseases or autoimmune disorders highly desired
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
Flexibility to travel domestically and internationally as required
Strong commitment to compliance and ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Salary is commensurate with experience
Kiniksa Benefits Summary - USA
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Kiniksa Pharmaceutical