4 Jobs in Lexington, MA
Kiniksa Pharmaceuticals is Hiring a Senior Director, Clinical Operations Near Lexington, MA
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
- 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
Job Summary
Full Time
Pharmaceutical
$105k-127k (estimate)
06/08/2024
07/05/2024
kiniksa.com
LEXINGTON, MA
100 - 200
2015
MICHAEL MEGNA
$10M - $50M
Pharmaceutical
Related Companies
About Kiniksa Pharmaceuticals
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. We have an experienced team that has advanced multiple product candidates in parallel that focus on a range of debilitating diseases with significant unmet medical need. We continue to explore expanding our pipeline in order to develop life-changing medicines for patients who need it most. We are focused on hiring and retaining a highly skilled team that has extensive experience and ...
specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a brilliant team to support our mission of building a global, generational company. Our benefits are competitive, and we offer dynamic career opportunities across our organization fostering a culture that embraces passion and rapid execution.
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The job skills required for Senior Director, Clinical Operations include Leadership, Clinical Operations, Planning, Problem Solving, Clinical Trial, Effective Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Director, Clinical Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Director, Clinical Operations. Select any job title you are interested in and start to search job requirements.
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