Executive Director/Vice President, Biostatistics

Job Description

Job Description

Salary:

About Acrivon Therapeutics, Inc.

Acrivon is a clinical stage biopharmaceutical company discovering and developing precision oncology 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 2 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 companys 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 companys 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. The company also has a preclinical 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 Executive Director/Vice President, Biostatistics to lead Acrivons biostatistics efforts in both clinical and diagnostics development programs.The successful candidate will play a critical role in the strategy and execution of Acrivons 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.
• 8-10 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.