General Supervisor, CLIA Immunohistochemistry (IHC) Laboratory and Senior Manager/Associate Director of Clinical Laboratory Services
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:
This position will lead Acrivon's CLIA laboratory IHC operations. The successful candidate will play a critical role in supporting our biomarker-driven clinical development programs and work closely with our biomarker platform team to advance our precision medicines in oncology.
Location:
This position will report to the Laboratory Director and be based in our Watertown, MA facility.
Duties and Responsibilities:
- Oversee and manage daily IHC laboratory operations, ensuring the highest quality of patient care while meeting regulatory and compliance standards.
- Supervise, mentor, and train IHC laboratory staff, conducting performance reviews and competency assessments.
- Maintain proper equipment operation and oversee new test implementation.
- Troubleshoot and resolve laboratory issues, correct errors, and document quality control.
- Ensure efficient, timely, and high-quality IHC slide production for both bright field and fluorescence techniques.
- Collaborate with other departments, including clinical development, biomarker development, and quality assurance.
- Assist in CLIA/CAP preparation and standardization efforts.
- Implement and enforce all Standard Operating Procedures (SOPs) and Personal Protective Equipment (PPE) protocols.
- Conduct basic data analysis to monitor lab operation and performance.
- Participate in new method and procedure change validations and documentation.
- Stay current with the latest trends in IHC methods and testing, sharing knowledge with Acrivon leadership and staff.
- Work on special projects as assigned by management.
Required Skills/Abilities:
- Minimum of Bachelor's degree in histology, biology, or related field.
- Histotechnologist (HTL) certification from ASCP required.
- Minimum of 7 years of IHC-specific experience, including both bright field and fluorescence techniques.
- Strong knowledge of HIPAA, CAP, and CLIA regulations.
- Excellent communication, problem-solving, and leadership skills.
- Ability to participate constructively on cross-functional and diverse teams.
- Proficiency in Microsoft Office and laboratory information systems.
- QIHC (ASCP) certification preferred.
- Prior supervisory or leadership experience in a clinical laboratory setting preferred.
- Experience with digital pathology systems preferred.
- Ability to stand for extended periods.
- Manual dexterity for operating laboratory equipment.
- Visual acuity for microscopic examination and computer use.
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.