Acrivon (NASDAQ: ACRV) is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.

Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2b trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.

In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target.

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

Position Overview:

The Principal Scientist/ Associate Director/Director will be a key member of Acrivon Therapeutics Clinical Development team and assist our clinical science efforts to:

• Support the development of two clinical stage assets currently being evaluated in cancer patients (ACR-368 and ACR-2316)

• Drive real-time analysis and monitoring of emerging clinical data (both safety and clinical activity)

• Be a key contributor in all the future clinical studies that will be executed by Acrivon in terms of design, data collection, data interpretation, and visualization of data summaries with various types of graph plots for corporate presentations
  
  

Location:

The position reports to the Chief Medical Officer and will be based out of the corporate headquarters in Watertown, MA.

Duties and Responsibilities:

• Collaborate within the Clinical Development Team on the review, analysis, and interpretation of study results and assure appropriate data review, accurate data reporting, timely and complete query closure, database quality and integrity, safety event and protocol deviation oversight, and tracking and timely reporting of study related samples, reports, and procedures.

• Support the leadership team through the development of powerful presentations to communicate study data results (e.g. waterfall, swimmer, and spider plots) to internal (e.g. board) and to external audiences in visually clear and appealing manner on behalf of the Company.

• Help support database control and integrity, data and sample tracking documents and processes, periodic reporting updates, regulatory responses, query issuance and tracking, and adherence to GCP and company standards.

• Work closely with the medical monitor to assure he/she is informed of pertinent study information.

• Proactively identify any study or program challenges by reviewing and monitoring of emerging clinical data related to safety, efficacy, protocol deviations, site performance, and query management.

• Develop and implement sound solutions to any identified issues in collaboration with the clinical study team and Clinical Research Organizations.

• Conduct literature reviews as needed for the interpretation of study data and development of next steps or improvements to workflow.

• In collaboration with internal/external experts and stakeholders on biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management, contribute to trial design including clinical protocols, ICF and CRF design, study procedures manuals, data review plans, statistical analysis plans, IRT, data entry guidelines, and medical monitoring and risk management plans.

• Support the development of additional program documents including pharmacy manuals, study procedures manuals, clinical SOPs, safety, and deviation tracking, and SIV materials.

• Support the development of clinical sections for various regulatory documents such as INDs, clinical study reports, investigator brochures, annual reports and updates, and NDAs.

• Serve as a clinical science representative on cross-functional teams as assigned.

Qualifications:

• Advanced degree in a life science field (PhD, or PharmD).

• A minimum of 4 years (Principal), 7 years (Associate Director), or 10 years (Director) relevant clinical research experience in pharmaceutical and/or biotech companies or from a clinical trial organization (direct translational experience is desirable).

• Experience in execution and interpretation of early, mid, and late stage oncology clinical studies, with vast experience with diverse trial endpoints including those with translational/biomarker and quality of life assessments.

• Experience managing and tracking clinical data and critically reviewing study documents with exceptional attention to detail and ability to analyze and interpret clinical data.

• Experience working with and managing CRO(s); experience working in joint research collaborations desirable.

• Outstanding oral and written communication skills and swift ability to work efficiently with a multi-disciplinary clinical team at different geographical locations and (US) time zones.

• Demonstrably strong IT skills, including command of the Microsoft Office Suite, SharePoint, Egnyte, Zoom, MS Teams, etc.

• Deep expertise with one or more data visualization platforms (e.g. Spotfire, Tableau, Prism, etc) to develop key clinical graphs, e.g. heatmaps, waterfall, spider, and swimmer plots, and variations thereof, in a timely manner. Experience with a programming language (e.g. R, Python, SAS) is desirable but not required.