GentiBio is seeking a driven, collaborative Director/Sr. Director of Clinical Operations to join our growing Clinical team. The successful candidate will be responsible for input into design and oversight of execution of GentiBio’s clinical studies. This is a key leadership role, with the opportunity to establish clinical operations practices, ensure regulatory compliance, and oversee clinical Contract Research Organization activities. This role will report into the CMO and partner across a dynamic organization with a strong ‘can do’ attitude to progress the GentiBio portfolio into the clinic.
Responsibilities- Develop and ensure effective implementation of compound development and study execution plans
- Ensure accurate and up-to-date study and program information within relevant tracking systems and provide regular updates
- Proactively identify, risk-manage, and resolve issues that arise during study and program conduct to ensure timely study delivery; manage escalation of study and program-related issues
- Oversee the development of clinical operational budgets and timelines for Program(s). Partner with study team(s) to ensure accurate forecasting, tracking, and timely review of study budgets. Facilitate timely escalation of variances
- Develop relevant SOPs and collaborate to ensure high quality and compliant execution of clinical studies
- Oversee and ensure the development of accurate program and study-level plans. Actively contribute to the project team(s), supporting the strategic planning and execution of clinical development plans
- Support the CMO with the implementation of initiatives, serve as liaison/change management champion for Clinical Operations
- Translate corporate goals into relevant, tangible and measurable objectives for the Clinical Operations team and third-party vendors
- Manage all clinical research operations activities including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones
- As the portfolio grows, hire, train and develop a high functioning Clinical Operations team
Qualifications & Education- BS degree in science or health-related field is required, with advanced degree in a health-related field is preferred
- 10+ years of direct clinical trial management experience
- Must have multi-trial, early and late phase clinical trial experience in a leadership role
- Experience in cell therapy and Type 1 diabetes preferred
- Location in the Greater Boston area preferred
- Strong communication skills with ability to summarize complex issues clearly and succinctly
- Ability to maintain a high level of attention to detail without losing sight of the big picture
- Keen business sense and thorough understanding of industry trends and competitive landscape
- Strong interpersonal skills and demonstrated leadership with ability to adapt quickly to changing environments
- Demonstrated ability to work collaboratively with others to solve complex problems
About us: GentiBio is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology from Seattle Children’s Research Institute, Benaroya Research Institute, and MIGAL Galilee Research Institute. We are focused on the development of EngTregs programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio’s proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T-cell therapeutics. Our corporate operations are in both Cambridge, MA and Seattle, WA.
We are building an exceptional company culture focused on empowerment, care for one another, an appreciation for diversity and inclusion, and the development of our people. We are looking for people who are not only incredible experts in their field, but also individuals who are looking to contribute to building and modeling an outstanding company culture – and having fun while doing so.
Benefits: GentiBio benefits programs are designed to promote the health and well-being of our people and their families. We offer a competitive benefits package including a choice from 3 medical plan options, dental and vision plans, flexible spending accounts (FSAs), health saving accounts (HSAs) with employer contribution, disability & life insurances, 401(k) plan with company match, unlimited PTO, parental leave for delivering and non-delivering parents, commuter subsidy, and more!
EEO Statement: GentiBio is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & staffing agencies: GentiBio does not accept agency resumes unless contacted directly by internal GentiBio Talent Acquisition. Please do not forward resumes to GentiBio employees or any other company location; GentiBio is not responsible for any fees related to unsolicited resumes.
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