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Acrivon Therapeutics, Inc. · 3 weeks ago

Principal Scientist/Associate Director/Director, Clinical Science

Watertown, MA

Full-time

Onsite

Lead/Staff

4+ years exp

Acrivon Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on discovering and developing precision medicines. The Principal Scientist/Associate Director/Director will play a crucial role in supporting clinical science efforts and analyzing emerging clinical data for two clinical stage assets currently being evaluated in cancer patients.

BiotechnologyHealth CareOncologyTherapeutics

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 (e.g. board) and to 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 assure he/she is informed of pertinent study information

Proactively identify any study or program challenges by reviewing and monitoring of emerging clinical data related to safety, efficacy, protocol deviations, site performance, and query management

Develop and implement sound solutions to any identified issues in collaboration with the clinical study team and Clinical Research Organizations

Conduct literature reviews as needed for the interpretation of study data and development of next steps or improvements to workflow

In collaboration with internal/external experts and stakeholders on 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 the development of additional program documents including pharmacy manuals, study procedures manuals, clinical SOPs, safety, and deviation tracking, and SIV materials

Support the development of clinical sections for various 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

Qualification

Clinical research experienceData visualization platformsOncology clinical studiesMicrosoft Office SuiteData analysisInterpretationCRO managementOralProgramming language RProgramming language PythonProgramming language SASWritten communicationAttention to detail

Required

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 vast experience with diverse trial endpoints including those with translational/biomarker and quality of life assessments

Experience managing and tracking clinical data and critically reviewing study documents with exceptional attention to detail and ability to analyze and interpret clinical data

Experience working with and managing CRO(s); experience working in joint research collaborations desirable

Outstanding oral and written communication skills and swift ability to work efficiently with a multi-disciplinary clinical team at different geographical locations and (US) time zones

Demonstrably strong IT skills, including command of the Microsoft Office Suite, SharePoint, Egnyte, Zoom, MS Teams, etc

Deep expertise with one or more data visualization platforms (e.g. Spotfire, Tableau, Prism, etc) to develop key clinical graphs, e.g. heatmaps, waterfall, spider, and swimmer plots, and variations thereof, in a timely manner