Principal Scientist/Associate Director, Clinical Science - Acrivon Therapeutics

Acrivon (NASDAQ: ACRV) 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 registrational-intent Phase 2b 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. The company reported positive clinical data for ovarian and endometrial cancers in April 2024, and in September 2024 it reported additional positive clinical data for endometrial cancer, including a confirmed overall response rate of 62.5% (95% CI, 30.4 - 86.5) and further validation of its prospective OncoSignature selection of patients predicted sensitive to ACR-368 by showing segregation of responders in OncoSignature-positive versus OncoSignature-negative patients (p = 0.009). The median duration of treatment was not yet reached, but the duration on study was 6 months at the time of the data cut.

In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine 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 demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target.

Acrivon has developed AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs.

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 will be a key member of Acrivon Therapeutics Clinical Development team and lead 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 and data interpretation

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 presentations to communicate study data results (e.g. waterfall, swimmer, and spider plots) to internal (e.g. board) and to external audiences.
• 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.
• 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 8 years relevant clinical research experience in pharmaceutical and/or biotech companies (direct translational experience highly desired).
• Experience in execution and interpretation of early and mid-stage oncology clinical studies, especially those with translational/biomarker 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.
• Expertise with one or more data visualization platforms (e.g. Spotfire, Tableau, Prism, etc) to develop key clinical graphs, e.g. waterfall, spider, and swimmer plots.

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.