Job Description
Job DescriptionSalary: $140,000 - $170,000
Acrivon(NASDAQ: ACRV)is a clinical stage biopharmaceutical company discovering and developing precision medicinesutilizingits proprietary GenerativePhosphoproteomicsAP3 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 GenerativePhosphoproteomicsAP3 platform iscomprisedof a growing suite of powerful,internally-developedtools, 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 drugdiscovery, andrapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivonis currently advancing its lead program, ACR-368 (also known asprexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2b 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 onOncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368OncoSignatureassay for the identification of patients with endometrial cancer who maybenefitfrom ACR-368 treatment.
In addition to ACR-368,Acrivonis alsoleveragingits proprietary GenerativePhosphoproteomicsAP3 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, asobservedin 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 wasobservedat 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 shrinkageobservedat DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target.
Our global teamoperatesout of two leading life science clusters, Watertown, MA andMediconVillage in Lund, Sweden.
Position Overview:
TheClinical Trial Manager (CTM)will be a key member of Acrivon Therapeutics Clinical Operations Team and will be responsible for providing oversight to a Phase I/II clinical trial ensuring milestones are being met. This position will be a based in Watertown, MA.
The Clinical Trial Manager position focuses on strategic planning, implementation, and management of a complex clinical trial. Dedicated to overseeing trials from start-up through close-out, fostering relationships with investigator sites, vendors, and consultants to ensure regulatory compliance and timely deliverables.
Duties and Responsibilities:
- Oversees site initiation, subject enrollment, clinical monitoring, compliance at clinical sites, and metrics management with CROs, central labs, and external vendors.
- Ensures high-quality execution throughout clinical trial initiation, conduct, and closure.
- Manages study budgets, contracts with vendors, and negotiates agreements to track and control costs effectively.
- Guides cross-functional teams in achieving study timelines, strategies, goals, and quality benchmarks.
- Evaluates and ensures effective oversight of Contract Research Organizations (CROs) and other vendors, fostering strong partnerships.
- Communicates effectively with clinical trial sites to maintain project momentum.
- Updates stakeholders on trial progress to align expectations, priorities, and deliverables.
- Contributes to study-level budget development and takes responsibility for budget management.
- Identifies and addresses risks associated with clinical studies and investigator sites, implementing corrective actions as needed.
- Leads operational activities detailed in study plans, SOPs, and other study-related documents.
- Reviews critical study documents, including protocols, informed consent forms, and operational materials.
- Assesses monitoring visit reports to verify site training adequacy and resolve any outstanding issues promptly.
Requirements and Qualifications:
- Minimum of a bachelors degree in a scientific or health-related discipline.
- Minimum of 5+ years of Clinical Operations and Clinical Trial Management experience at a contract research organization, biotech or pharmaceutical company preferably in early to mid-phase oncology
- Proven leadership skills managing cross-functionally in a matrix environment.
- Demonstrated ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
- Strong verbal and written communication skills with ability to communicate and work productively in a team environment.
- Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel
- Proven ability to multi-task and work collaboratively as well as independently.
- Ability to organize and manage multiple priorities required.
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