Senior Director, Clinical Operations
Company: Kiniksa Pharmaceutical
Location: Lexington
Posted on: April 17, 2024
Job Description:
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.
Keywords: Kiniksa Pharmaceutical, Arlington , Senior Director, Clinical Operations, Executive , Lexington, Massachusetts
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