VP or SVP, Regulatory Affairs

Job Description

Job Description

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 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 company’s 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 Summary

Acrivon Therapeutics is seeking an accomplished and strategic Vice President or Senior Vice President of Regulatory Affairs to lead the global regulatory function and serve as a key member of the Development Leadership Team. This individual will be responsible for developing and executing innovative regulatory strategies that accelerate the advancement of Acrivon's precision oncology pipeline from early clinical development through registration and commercialization.

 

The successful candidate will lead regulatory strategy across all development programs, working closely with clinical, translational medicine, biomarker, CMC, quality, and executive teams. This person will serve as the primary regulatory liaison to global health authorities and help shape development strategies that advance Acrivon’s precision medicine approach while ensuring compliance with global regulatory requirements. This position is based onsite at Acrivon Therapeutics’ headquarters in Watertown, Massachusetts.

 

Key Responsibilities

Regulatory Leadership & Strategy

• Develop and execute global regulatory strategies for Acrivon's oncology pipeline, including companion diagnostic and biomarker-driven development programs.
• Provide strategic regulatory guidance across all stages of development, from preclinical through commercialization.
• Lead regulatory planning for INDs, CTAs, ODDs, end-of-Phase meetings, breakthrough therapy designations, accelerated approval pathways, NDAs, BLAs, MAAs, and other key regulatory milestones.
• Evaluate evolving global regulatory requirements and proactively assess their impact on company programs and strategy.
• Serve as the primary regulatory advisor to executive leadership and the Board of Directors as needed.

Health Authority Interactions

• Lead all interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other regulatory agencies.
• Develop briefing documents, meeting strategies, and negotiation approaches for regulatory interactions.
• Represent the company during regulatory meetings and inspections.
• Build and maintain productive relationships with regulatory agencies and external regulatory experts.

Regulatory Operations & Submissions

• Oversee preparation, review, and submission of regulatory filings and correspondence.
• Ensure high-quality, compliant, and timely regulatory submissions.
• Provide strategic oversight for submission planning, document development, and regulatory publishing activities.
• Establish and maintain regulatory processes, systems, and standards that support organizational growth.

Cross-Functional Leadership

• Partner closely with Clinical Development, Clinical Operations, Translational Medicine, Biomarker Sciences, Medical Affairs, CMC, Quality, Legal, and Program Management teams.
• Integrate regulatory strategy into overall development and business objectives.
• Provide regulatory leadership for companion diagnostic and precision medicine development initiatives.
• Support diligence activities, partnership discussions, and business development opportunities as needed.

People Leadership

• Foster a culture of accountability, collaboration, scientific rigor, and continuous improvement.
• Manage external consultants, CROs, and regulatory vendors as appropriate.
• Scale regulatory capabilities to support company growth and pipeline expansion.

Qualifications

Required

• Advanced scientific degree (PhD, PharmD, MD, or equivalent); additional regulatory certification is a plus.
• VP: Typically 15+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry.
• SVP: Typically 20+ years of regulatory affairs experience with demonstrated executive leadership responsibilities.
• Significant experience leading regulatory strategy for oncology development programs.
• Proven success with INDs, global clinical development, and major health authority interactions.
• Experience supporting or leading regulatory activities associated with precision medicine, biomarkers, and/or companion diagnostics.
• Demonstrated track record of regulatory achievements that have advanced products through key development milestones.
• Strong understanding of U.S. and international regulatory frameworks and expedited development pathways.
• Exceptional leadership, communication, negotiation, and influencing skills.

Preferred

• Experience supporting NDA, BLA, MAA, or equivalent marketing applications.
• Prior experience in a clinical-stage oncology biotechnology company.
• Experience working within highly collaborative, fast-paced, entrepreneurial environments.
• Familiarity with AI-enabled, biomarker-driven, or precision medicine development approaches.

 

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.