Vice President, Biostatistics
Vice President, Biostatistics
Acrivon Therapeutics, Inc.
Watertown, MA
See who Acrivon Therapeutics, Inc. has hired for this role
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.
- 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.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Other -
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Acrivon Therapeutics, Inc. by 2x
See who you knowGet notified about new Vice President jobs in Watertown, MA.
Sign in to create job alertSimilar jobs
People also viewed
-
Senior Vice President, Delivery and Operations
Senior Vice President, Delivery and Operations
-
General Manager
General Manager
-
Executive Director, Portfolio Operations
Executive Director, Portfolio Operations
-
Managing Director of Accelerating Decarbonization
Managing Director of Accelerating Decarbonization
-
Vice President of Revenue Operations - Strategic Leadership & Growth
Vice President of Revenue Operations - Strategic Leadership & Growth
-
Executive Creative Director
Executive Creative Director
-
Executive Director
Executive Director
-
Senior Director/Vice President, Development Project Leader
Senior Director/Vice President, Development Project Leader
-
Vice President of Strategy & Risk Management in Healthcare
Vice President of Strategy & Risk Management in Healthcare
-
Executive Vice President, US
Executive Vice President, US
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More