Search

Clinical Trial Manager (CTM or Sr. CTM)

Acrivon Therapeutics
locationWatertown, MA, USA
PublishedPublished: 6/14/2022
Healthcare
Full Time

Job Description

Job DescriptionSalary: $135,000 - $180,000

About Acrivon Therapeutics, Inc.

Acrivon is a clinical stage biopharmaceutical company discovering and developing precision 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.

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, and additional internally discovered oncology development candidates.

Our global team operates out of two leading life science clusters, Watertown, MA and Medicon Village in Lund, Sweden.

Position Overview:

TheClinical Trial Manager (CTM / Sr. CTM) will be a key member of Acrivon Therapeutics Clinical Operations Team and will be responsible for providing oversight to the ARC-386 Phase II clinical trial. This position will be 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, cross-functional colleagues, and consultants to ensure GCP/ICH 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 and accountability.
  • Communicates effectively with study team and sites to maintain project momentum, direction and team effectiveness.
  • 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 or escalations as needed.
  • Lead operational activities detailed in study plans, SOPs, and other study-related documents.
  • Reviews / contribute to critical study documents, including protocols, manuals, informed consent forms, and operational materials.
  • Assesses monitoring visit reports to verify site training adequacy and resolve any outstanding issues promptly.
  • Lead study teams cross-functional vendor oversight efforts.

Requirements and Qualifications:

  • Minimum of a bachelors degree in a scientific or health-related discipline.
  • Minimum of 3+ 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 internal / external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
  • Mature, level-headed and organized with a can-do disposition.
  • 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.

Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...