Principal Scientist/Associate Director/Director, Clinical Science

Role Summary

The Principal Scientist/ Associate Director/Director will be a key member of Acrivon Therapeutics Clinical Development team and assist our clinical science efforts to support the development of two clinical stage assets (ACR-368 and ACR-2316), drive real-time analysis and monitoring of emerging clinical data (safety and clinical activity), and contribute to trial design, data collection, data interpretation, and visualization of data summaries for corporate presentations.

Responsibilities

• Collaborate within the Clinical Development Team on the review, analysis, and interpretation of study results and assure appropriate data review, accurate data reporting, timely and complete query closure, database quality and integrity, safety event and protocol deviation oversight, and tracking and timely reporting of study related samples, reports, and procedures.
• Support the leadership team through the development of powerful presentations to communicate study data results (e.g. waterfall, swimmer, and spider plots) to internal and external audiences in visually clear and appealing manner on behalf of the Company.
• Help support database control and integrity, data and sample tracking documents and processes, periodic reporting updates, regulatory responses, query issuance and tracking, and adherence to GCP and company standards.
• Work closely with the medical monitor to ensure they are informed of pertinent study information.
• Proactively identify any study or program challenges by reviewing and monitoring emerging clinical data related to safety, efficacy, protocol deviations, site performance, and query management.
• Develop and implement sound solutions to identified issues in collaboration with the clinical study team and Clinical Research Organizations.
• Conduct literature reviews as needed for interpretation of study data and development of next steps or workflow improvements.
• In collaboration with internal/external experts and stakeholders in biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management, contribute to trial design including clinical protocols, ICF and CRF design, study procedures manuals, data review plans, statistical analysis plans, IRT, data entry guidelines, and medical monitoring and risk management plans.
• Support development of additional program documents including pharmacy manuals, study procedures manuals, clinical SOPs, safety and deviation tracking, and SIV materials.
• Support development of clinical sections for regulatory documents such as INDs, clinical study reports, investigator brochures, annual reports and updates, and NDAs.
• Serve as a clinical science representative on cross-functional teams as assigned.

Qualifications

• Advanced degree in a life science field (PhD, or PharmD).
• A minimum of 4 years (Principal), 7 years (Associate Director), or 10 years (Director) relevant clinical research experience in pharmaceutical and/or biotech companies or from a clinical trial organization (direct translational experience is desirable).
• Experience in execution and interpretation of early, mid, and late stage oncology clinical studies, with diverse trial endpoints including translational/biomarker and quality of life assessments.
• Experience managing and tracking clinical data and critically reviewing study documents with attention to detail and ability to analyze and interpret clinical data.
• Experience working with and managing CROs; experience in joint research collaborations desirable.
• Outstanding oral and written communication skills and ability to work efficiently with a multi-disciplinary clinical team across geographical locations and time zones.
• Strong IT skills, including Microsoft Office Suite, SharePoint, Egnyte, Zoom, MS Teams, etc.
• Deep expertise with data visualization platforms (e.g., Spotfire, Tableau, Prism) to develop key clinical graphs (heatmaps, waterfall, spider, swimmer plots) in a timely manner. Experience with a programming language (R, Python, SAS) is desirable but not required.

Skills

• Data visualization and interpretation
• Clinical trial design and data management
• Cross-functional collaboration
• Biostatistics and clinical pharmacology awareness
• Regulatory documentation support

Education

• Advanced degree in a life science field (PhD, or PharmD).