[Hiring] Senior Medical Trial Supervisor @Outpacebio

About Outpace Bio

Outpace Bio is pioneering the way forward for mobile remedy for forged tumors by means of harnessing unmatched AI-powered protein design. Our undertaking is to program immune cells for enhanced serve as inside of sufferers, overcoming key obstacles akin to deficient tumor get admission to, vulnerable survival, antigen break out, and dose-related toxicity. By way of growing and integrating modular, plug-and-play era belongings, we’re creating mobile remedies with unparalleled efficacy, reworking how engineered T cells engage with most cancers and the immune gadget to ship life-changing results.Our multidisciplinary group of scientists, engineers, coders, and mobile remedy builders works on the chopping fringe of computational protein design, artificial biology, and immunology. In combination, we’re reimagining how cells serve as to release novel healing chances.Situated in Seattle’s colourful biotech hub overlooking scenic Lake Union, Outpace Bio is led by means of pioneers in computational protein design and engineered mobile remedies. Our tradition is constructed on a basis of admire and inclusion, which can be elementary to how we collaborate to revolutionize mobile remedy thru groundbreaking innovation rooted in rigorous science.

Our Dedication to Variety

At Outpace Bio, we imagine that the perfect acting groups come with other folks from all kinds of backgrounds and reviews. We’re dedicated to cultivating an open, numerous, and inclusive tradition for all staff. Spotting that the most efficient applicants don’t at all times fit all standards of the process description, we inspire you to use in the event you assume you can be a excellent are compatible for the function and are impressed by means of our undertaking to treatment illness by means of pushing the limits of biology.

Our Momentum

In August 2024, Outpace Bio secured an oversubscribed $144 million Sequence B financing, led by means of RA Capital Control and supported by means of a premier syndicate of existence science buyers. This investment speeds up our pipeline of programmed T mobile remedies, together with our lead candidate OPB-101, a mesothelin-specific chimeric antigen receptor (CAR) T mobile enhanced by means of Outpace’s proprietary OUTSMART™, OUTLAST™, OUTSPACER™, and OUTSAFE™ applied sciences. OPB-101 is advancing towards IND clearance and primary dosing in 2025 for sufferers with complex platinum-resistant ovarian cancers. The Sequence B funding additionally helps the growth of our pipeline, enabling us to expand further transformative remedies leveraging our leading edge plug-and-play era platform.

The Senior Medical Trial Supervisor (Sr CTM), with toughen and steerage from Medical Operations management, is accountable for all operational sides of assigned cell-therapy scientific trial(s) from setup thru ultimate file. The Sr CTM guarantees assigned trials are achieved with high quality, compliance and potency, based on rules, timelines and finances. The candidate will coordinate the actions of a number of different scientific group individuals (e.g., CRAs, CTAs, Logistics, and so forth.), in addition to oversee CROs, distributors and experts.

Tasks (Place obligations would possibly come with, however aren’t restricted to):

Trial-level oversight and management of assigned cell-therapy scientific trial(s) in a cross-functional setting.

Obtains and maintains in-depth figuring out of the trial protocol and linked procedures to be able to give a contribution strongly to trial group wisdom by means of sharing absolute best practices, making suggestions for steady development and offering coaching as suitable/required.

Develops sturdy seller and web page relationships and guarantees continuity of relationships thru all levels of the trial.

Develops recruitment and slot control methods.

Management of assigned conferences (cross-functional [internal], seller, and/or investigator) and provision of standard updates on trial standing, e.g., time table building, mins curation and submitting.

Chance id, mitigation, and control, together with well timed factor overview, escalation, and control to toughen pattern research and chance prevention.

CTMS and eTMF control to make sure compliance/inspection readiness, toughen pattern analyses and toughen timelines.

Evaluation of EDC design specs, participation in consumer acceptance checking out, and contribution to building and overview of related plans and of completion tips.

Evaluation scientific knowledge to make sure well timed access and readiness for knowledge overview conferences and toughen knowledge cleansing/question procedure.

Evaluation scientific tracking experiences to make sure well timed of completion and id of problems.

Entire and take care of inner scientific trial metrics, dashboards and different inner updates.

Ensure that trials are performed based on Outpace Bio and ICH/GCP requirements.

Coordinates & manages quite a lot of duties in collaboration with different roles to reach web page readiness, akin to trial fabrics and popularity of drug transport/receipt in keeping with process.

Different obligations as assigned.

{Qualifications} (Required):

Bachelor’s Stage or ex-US similar required.

Minimal of 6 years of revel in within the scientific analysis business, together with no less than 3 years of trial control revel in.

Tough oncology revel in required together with early-stage revel in and mobile or gene remedy (extremely complicated akin to CAR-T).

Sturdy analytical and important considering talents to guage complicated problems from more than one views to actively expand methods and pressure good move making to toughen acceleration of trial timelines and permit a well-run trial.

Very good organizational and time control talents, sturdy consideration to element.

Skill to paintings independently and thrive in a fast paced evolving setting.

Just right figuring out of FDA and ICH GCP tips.

Very good verbal and written verbal exchange talents.

The wage vary is in line with Outpace Bio’s affordable estimate of base wage for this function on the time of posting. Exact base wage shall be in line with quite a few components together with talents, revel in, and different linked components accredited by means of regulation.

Operating at Outpace provides an exhilarating alternative to give a contribution to groundbreaking analysis that has the prospective to grow to be the lives of other folks world wide.

Outpace Bio Overall Rewards

Complete time staff and their eligible dependents would possibly join in Outpace’s scientific, dental, imaginative and prescient, existence insurance coverage, incapacity, versatile spending account, and 401k plan. As well as, staff would possibly obtain inventory possibility grants to be defined of their be offering of employment. Outpace staff revel in versatile PTO, paid unwell depart which complies with native necessities, and fifteen paid vacations plus a wintry weather shutdown. Outpace additionally provides a beneficiant paid parental depart coverage to all common full-time staff.

Outpace Bio is dedicated to a various staff. Employment selections referring to recruitment and choice shall be made with out discrimination in line with race, colour, faith, nationwide starting place, gender, age, sexual orientation, bodily or psychological incapacity, genetic data or function, gender identification and expression, veteran standing, or different non-job linked traits or different prohibited grounds laid out in appropriate federal, state and native regulations.

Candidates should be approved to paintings in the US. If you’re legally approved to paintings in the US now, or sooner or later with none type of sponsorship, we inspire you to use.

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