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Clinical Trial Associate

2 months ago

Watertown, United States Acrivon Therapeutics Full time

Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. These distinctive capabilities enable AP3’s direct application for drug design optimization for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates.

 

Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. Acrivon’s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered preclinical stage pipeline programs. These include ACR-2316, a potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors, and a cell cycle program with an undisclosed target.


Our global team operates out of two leading life science clusters, Watertown, MA and Medicon Village in Lund, Sweden.

 

Position Overview:

 

The Clinical Trial Associate (CTA) will be a key member of Acrivon Therapeutics’ Clinical Operations Team and provides administrative support for clinical trial programs. This position will be a based in Watertown, MA.

 

The CTA will independently perform tasks related to supporting operational strategy, planning, and execution of clinical studies in a fully outsourced model. Reporting to the SVP, Clinical Operations, this position assists the Clinical team with establishing key practices and procedures in preparation for future expansion and growth.

 

Duties and Responsibilities:


  • Responsible for assisting and providing support to the members of the Clinical Operations team in order to facilitate the management clinical trial processes, complying with international Good Clinical Practice (GCP) guidelines/regulations.
  • Collaborate with Clinical Trial Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
  • Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, startup progress, screening/enrollment, and others as necessary.
  • Coordinate agenda distribution & minute taking for internal and/or external study team meetings.
  • Coordinate logistics for meetings, including booking conference rooms and arranging necessary resources.


    Qualifications include:

    • Bachelor's degree required.
    • Experience in a healthcare or research setting is preferred.
    • Strong verbal and written communication skills with ability to communicate and work productively in a team environment.
    • Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel.
    • Proven ability to multi-task and work collaboratively as well as independently.
    • Ability to organize and manage multiple priorities required.

       

      Acrivon Therapeutics is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, Acrivon Therapeutics complies with applicable state and local laws governing nondiscrimination in employment.