Clinical Trial Manager

3 days ago

Watertown, Massachusetts, 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 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:

The Clinical 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 bachelor's 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.

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