Development Operations

Crossbow Therapeutics, Inc., is a biotechnology company determined to improve the lives of people with cancer by unlocking the therapeutic potential of T-cell receptor (TCR)-mimetic antibodies. The company’s T-Bolt™ therapies are next-generation, easily assembled immunotherapies directed with high precision at previously unreachable cancer cell targets. Crossbow’s efficient and selective approach is designed to target the entire universe of cancer proteins, dramatically expanding the potential of antibody therapy to address many types of cancer.

Join us on our bold quest to broaden the benefits of immunotherapy and improve the lives of people living with cancer. For more information, visit us at www.crossbowtx.com.

About The Opportunity

As a member of our Clinical Trial team, you'll leverage your scientific and project management skills to support the Regulatory and Development Operations team on a number of cross-functional workstreams. You'll collaborate with internal and external representatives in clinical operations, supply, safety, data management, clinical research, translational science, and clinical pharmacology. You'll work with the outsourced CRO to ensure streamlined processes, and help build internal systems for clinical trial oversight. Our research and development team includes a group of scientists and drug developers with deep industry experience. The position will report to the Senior Director, Regulatory Affairs and Development Operations.

A great fit for this role would be someone who is:

Detail-oriented, motivated, and driven
A scientific professional who can balance project details with broader company goals
A problem-solver who can identify issues and be solution focused
An energetic and positive influence who is driven by their passion for impacting people with cancer

Responsibilities

Manage end-to-end life cycle of clinical biospecimens and associated data
Assist with developing processes (such as departmental SOPs)
Review, author and edit key clinical documents (protocol, ICF, ethics committee documents, etc.)
Participate on the clinical trial team, ensuring that timelines and deliverables are aligned with corporate objectives.
Support the planning and delivery of operational activities relating to clinical trials
Partner effectively with external Clinical Research Organizations (CROs)
Identify and mitigate potential risks and challenges with clinical trials, implementing
proactive strategies to optimize outcomes
Create and maintain clinical development dashboards, ensuring accurate and timely information
Support systems for data management flow to ensure accurate, timely and efficient processes are established.
Support integrated activities to ensure high quality regulatory submissions.
Coordinate receipt and transfer of biospecimens as needed between central labs, analysis labs, and biorepository vendor
Reconcile biospecimen information captured across clinical study and vendor databases
Follow-up and resolve discrepancies by communicating with sites/CROs and vendors
Collaborate with external labs/vendors to ensure PK and/or biomarker data are delivered in accordance with study-specific timelines (i.e., data review meetings, biomarker testing schedules, etc.) and/or SOPs
Identify and help resolve specimen collection, processing, transportation, and testing errors/issues as required
Create and/or distribute specimen management metrics, listings, and reports to relevant study team members and/or in meetings as needed
Contribute to departmental budget development and forecasting
Approve study invoices for specimen services and track invoices against contracts

What you should have:

Bachelor's Degree, preferably in a scientific discipline or health-related field
At least two years of relevant industry experience
Excellent proficiency with Excel/Google sheets
Ability to identify and resolve complex problems

To apply for this role: Send your resume directly to apply@crossbowtx.com

Location: This position is a hybrid opportunity with periodic travel to the Crossbow location at 1030 Massachusetts Ave. Suite 210, Cambridge, Massachusetts and travel for performing the role, as needed.

To all agencies: All resumes submitted by search firms/employment agencies at Crossbow via email, the internet, or in any form and/or method will be deemed the sole property of Crossbow Therapeutics and no fee will be paid by Crossbow, unless such search firms/employment agencies were engaged by Crossbow for this position and a valid agreement is in place.

A note about recruitment scams: Please be aware of potential recruitment scams, which can appear like legitimate work opportunities where the scammer pretends to work at Crossbow Therapeutics. To help protect yourself from those types of scams, please know that

Crossbow will never ask for money or fees at any point during the interview process - if you are being asked to send money as part of your interaction, do not send money;
Crossbow never asks applicants to communicate through Telegram or Skype - if you are being asked to download Telegram or Skype for a job interview, do not download;
Crossbow employees will only email you from an official @crossbowtx.com email account.

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