Principal Scientist/Associate Director/Director, Clinical Science
3 months ago
Watertown
Job DescriptionSalary: $170,000 - $220,000 Acrivon(NASDAQ: ACRV)is a clinical stage biopharmaceutical company discovering and developing precision medicinesutilizingits proprietary GenerativePhosphoproteomicsAP3 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 GenerativePhosphoproteomicsAP3 platform iscomprisedof a growing suite of powerful,internally-developedtools, 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 drugdiscovery, andrapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivonis currently advancing its lead program, ACR-368 (also known asprexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2b 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 onOncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368OncoSignatureassay for the identification of patients with endometrial cancer who maybenefitfrom ACR-368 treatment. In addition to ACR-368,Acrivonis alsoleveragingits proprietary GenerativePhosphoproteomicsAP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the companys second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, asobservedin preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement wasobservedat DL1 and 2 using the companys clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkageobservedat DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target. Our global teamoperatesout of two leading life science clusters, Watertown, MA andMediconVillage in Lund, Sweden. Position Overview: The Principal Scientist/ Associate Director/Directorwill be a key member ofAcrivonTherapeutics Clinical Development team andassistour clinical science effortsto: • Support thedevelopmentoftwoclinical stageassets currentlybeingevaluated in cancer patients(ACR-368and ACR-2316), • Drivereal-time analysis and monitoring ofemerging clinical data (bothsafety and clinical activity), • Bea key contributor in all the futureclinicalstudies that will beexecutedbyAcrivonin terms of design,data collection,datainterpretation, and visualization of data summaries withvarious typesofgraph plotsfor corporate presentations Location: The position reports to the Chief Medical Officer andwill be based out of the corporate headquarters in Watertown, MA. Duties and Responsibilities: • Collaborate within the Clinical Development Team on the review, analysis, and interpretation of study results and assureappropriate datareview,accuratedata reporting,timelyand complete query closure, database quality and integrity, safetyeventand protocol deviation oversight, and tracking andtimelyreporting of study related samples, reports, and procedures., • Support the leadership team through the development ofpowerfulpresentations to communicate study data results (e.g.waterfall, swimmer, and spider plots) to internal (e.g.board) and to external audiencesin visually clear and appealing manneron 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 toassurehe/she is informed of pertinent study information., • Proactivelyidentifyany study or program challenges by reviewing andmonitoring ofemerging clinical data related to safety, efficacy, protocol deviations, site performance, and query management., • Develop and implement sound solutions to any identified issuesin collaboration with the clinical study team andClinical Research Organizations., • Conduct literature reviews as needed for the interpretation of study data and development of next stepsor 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 ofadditionalprogram 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. Qualifications: • Advanced degree ina lifescience field(PhD, or PharmD)., • Aminimum of4years (Principal),7years(Associate Director), or 10 years (Director)relevant clinical research experience in pharmaceutical and/or biotech companiesor from a clinical trial organization(direct translational experienceisdesirable)., • Experience in execution and interpretation of early,mid, andlatestageoncology clinical studies,with vast experience with diverse trial endpoints includingthose with translational/biomarkerandqualityoflifeassessments., • 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., • Deepexpertisewith one or more data visualization platforms (e.g.Spotfire, Tableau, Prism,etc)to develop key clinicalgraphs,e.g.heatmaps,waterfall, spider, and swimmer plots, and variations thereof,in a timely manner.Experience with a programming language (e.g.R, Python, SAS) is desirable but notrequired.