Director/Sr. Director, Clinical Operations
Company: GentiBio
Location: Seattle
Posted on: November 6, 2024
Job Description:
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 teamQualifications & 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 problemsAbout 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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Keywords: GentiBio, Federal Way , Director/Sr. Director, Clinical Operations, Executive , Seattle, Washington
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