Vice President, Biostatistics

1 month 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 company has reported initial positive clinical data from its ongoing registrational-intent Phase 2b trial of ACR-368 for patients with locally advanced or metastatic, recurrent platinum-resistant ovarian cancer or endometrial adenocarcinoma (data cut as of April 1, 2024), including a confirmed ORR (per RECIST 1.1) of 50% in the prospective cohort of OncoSignature-positive patients who were efficacy-evaluable. 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:

We are seeking an experienced and dynamic Vice President of Biostatistics to lead Acrivon’s biostatistics efforts in both clinical and diagnostics development programs.  The successful candidate will play a critical role in the strategy and execution of Acrivon’s biomarker-driven clinical development through co-development of our pioneering drug-tailored predictive biomarker tests and working closely with the Acrivon biomarker platform team to unlock the value and promise of our precision medicines in oncology and beyond.  The position will report to the Chief Operating Officer and be based in Watertown, MA.

 

Duties and Responsibilities: 

  • Work closely with CRO statisticians in the design, protocol development, statistical analysis plan development, and interpretation of exploratory and pivotal drug studies, ensuring robust methodology and compliance with regulatory standards.
  • Work closely with diagnostic partner statisticians in the design, protocol development, statistical analysis plan development, and interpretation of critical studies. These include development, verification and validation studies, ensuring robust methodology and compliance with QSR requirements.
  • Align biostatistics strategy and activities with cross-functional Acrivon teams.
  • Support close interactions with other line functions including research, clinical development, biomarker development, data science, regulatory affairs, and quality.
  • Model and analyze critical data sets from both clinical and diagnostic development studies to support real-time decision making and evolution of strategy. This is a hands-on process.
  • Support FDA submissions and attend FDA meetings, providing the (often substantial) required biostatistics contributions.


    Qualifications include:

    • PhD in biostatistics, statistics, mathematics, or related field.
    • At least 10 years’ experience in biostatistics for clinical and diagnostic development, with companion diagnostic experience preferred.
    • Solid knowledge of statistical methods underlying diagnostic and clinical development and validation studies, including mixed effects regression modeling, DOEs, binomial modeling, stability models, time-to-event models, bootstrapping, tests for association in categorical variables, etc.
    • Skill in practical application of statistical methods, with extensive experience in R or SAS.
    • Knowledge of the drug and diagnostics co-development process, particularly for companion diagnostics.
    • Excellent strategic thinking and problem-solving skills.
    • Demonstrated ability to work effectively in a collaborative, fast-paced team environment.
    • Strong communication and interpersonal skills, proficient in presenting scientific data and strategies to stakeholders including non-scientific audiences.

       

      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.

       

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