About Acrivon Therapeutics, Inc.
Acrivon (NASDAQ: ACRV) 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 enables 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, referred to as patient responders. The name Acrivon (derived from Greek for “accurate”) embodies how our OncoSignature® tests link the patient’s active tumor-driving mechanisms with the drug’s mode-of-action to accurately match our therapies with patients who will benefit independent of underlying genetic tumor alterations.
Acrivon is currently advancing its lead candidate, ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types, which the AP3 platform predicts will have a high proportion of patient responders based on OncoSignature®-predicted sensitivity to ACR-368. In addition to ACR-368, Acrivon is also developing internally-discovered preclinical stage pipeline programs targeting critical nodes in the DNA Damage Response, or DDR, and cell cycle regulation pathways, including WEE1, a protein kinase, and PKMYT1, a closely related protein serine/threonine kinase.
Our global team operates out of two leading life science clusters, Watertown, MA and Medicon Village in Lund, Sweden.
The Senior Medical Director will be a key member of Acrivon Therapeutics’ Clinical Development Team and will be responsible for developing and executing the clinical strategies for Acrivon’s oncology programs. This position will be based in Watertown, MA, although exceptional remote candidates may be considered.
The Senior Medical Director will be responsible for executing clinical programs and delivering innovative, high-quality clinical study designs. He or she will integrate with internal and external clinical operation teams responsible for the day-to-day execution of the clinical programs. The Senior Medical Director will work with the entire Clinical Development Team to represent clinical activities on all cross-functional project teams.
Duties and Responsibilities:
- Support the Clinical Development Team in executing biomarker-driven strategic and operational clinical development plans in conjunction with a cross-functional team to include biomarker strategies and innovative study designs and methodologies through your cutting-edge medical and clinical development knowledge.
- Direct protocol development and work closely with clinical operations, translational medicine, biostatistics, pharmacology, and Acrivon’s clinical research organization (CRO).
- Support the research and translational medicine teams with the development of IND-enabling studies and clinical biomarker plans.
- Lead a cross functional team to execute the clinical development plan following all GCP requirements and internal compliance processes.
- Develop strategies, in conjunction with the team and in accordance with SOPs, GCP and regional regulations, to identify, monitor and resolve clinical program/trial operational issues.
- Participate in implementation of and medical oversight of ongoing or new clinical trials working with cross-functional teams and external vendors and advisors, and for ensuring the integrity of study conduct and patient safety.
- Manage and collaborate with external medical monitors and safety teams to safeguard patient safety in studies through excellence in design and ongoing safety/medical monitoring during study conduct and follow-up.
- Participate in analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy. Supports authorship of clinical study reports, publications, presentations, and new drug applications.
- Be a primary external face of the program(s) to key opinion leaders, clinicians, and others in the medical community. Ensures appropriate medical advisory expert input into all aspects of program strategy and execution.
- Communicate clearly across the organization, ensuring alignment cross-functionally, with leadership, and with external advisors.
- Establish relationships with key external clinical experts and institutions to ensure implementation of latest clinical thinking and guidelines into clinical development plans, and to establish collaborations for research innovation.
- In collaboration with others, represent the company as a senior medical spokesperson at appropriate scientific, medical, regulatory, business, business development, and other professional meetings.
- Provide medical support for regulatory documents creation (e.g., briefing books, INDs, NDAs etc.)
Requirements and Qualifications:
- MD or MD/Ph.D. with board certification in Oncology. A minimum of 3-5 years’ industry experience in clinical research and development, with at least 2 years in direct clinical trial management and oversight. Track record of both program development and execution.
- Comprehensive understanding of the drug development process and a proven track record of success in executing development programs
- Experience in both early- and late-stage clinical trials and track record of successful regulatory interactions.
- Prior clinical experience in phase 1-2 studies in oncology as clinical investigator or monitor / clinical director
- Strong scientific background, able to provide detailed guidance to clinical investigators
- High comfort level with translational biomarkers, clinical biostatistics and PK/PD modeling.
- Experience in biomarker development, validation and utility and continued engagement in nonclinical and clinical biomarker development and implementation.
- Understanding of clinical regulatory requirements
- Demonstration of effective teamwork as well as analytical and problem-solving abilities.
- Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate effectively across different levels of the organization. A track record of KOL engagement and external communication to medical and scientific audiences is desirable.
- Successful track record in planning and conducting of discovery and/or clinical science.
- Expert cross functional collaboration and leadership skills, including active development and maintenance of a close working relationship with functional, leadership, and governance team members to assure a closely coordinated program of activities based on common objectives.
- Ability to engage in research and development planning and technical execution appropriate to clinical research, translational biology and biomarker development at all stages of the drug development pathway.
- Good project management skills: ability to track and influence multiple activities led by various functional sub-teams to ensure deliverable of key milestones
- Travel may be required up to 25% in both the U.S.
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.