Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeuticsArvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the fieldSince its founding in 2013, arvinas’ protac® discovery engine has been driving the most significant breakthroughs in the industryArvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscienceThis includes two clinical-stage programs: arv-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and arv-471, which is being developed as a potential treatment for patients with breast cancer.
#teamarvinas is made up of more than 200 passionate and curious employees, whose diverse thoughts and perspectives are highly valuedArvinas employees embrace the freedom to pursue innovation, think creatively, and give backThey are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases arvinas is working to treatIt’s an exciting time to be in drug development and it’s an exciting time to be at arvinasBut don’t just take our word for it – here’s what arvinas employees are sayingFor more information, please visit www.arvinas.com.
Position summary
The clinical scientist is responsible for providing scientific support for all global clinical development activitiesThis cross-functional role includes assembling, evaluating, and presenting scientific and medical data, writing (clinical study protocols and protocol synopses, papers, abstracts, posters, etc.), and monitoring the competitive landscape and reviewing and summarizing relevant literature to provide strategic inputThis position requires a strong scientific background; in addition, the candidate must be able to clearly communicate concepts and information both in writing and via formal presentations to scientific and medical experts both internal and external to the companyThe selected individual will possess the ability to think creatively, function independently, deliver on timelines, have good strategic insights and have a detailed knowledge of the activities and procedures involved in clinical drug development.
The clinical scientist will collaborate with clinical operations, translational sciences, clinical pharmacology, regulatory, research and other functions within arvinas, as well as key partners external to the companyWorking closely with colleagues in clinical development, s/he will have a substantial role in the development of the clinical documents, the review of scientific and clinical data and the communication of data to the scientific and medical communities.
This position can be performed at our headquarters in new haven, ct, or we will consider a remote working arrangement, depending on candidate experience.
Principal responsibilities
Key responsibilities of this role include, but are not limited to:
Study data review and analysis
Lead development of medical monitor plans
Perform ongoing clinical data review and critical analysis of study data including partnering with clinical research physician in pharmacovigilance data reviews
Provide support as needed for clinical and scientific issues that may arise during study execution
Work closely with biostatisticians and programmers to plan analyses of clinical data
Support data outputs for board meetings, analyst events
Clinical document development
Lead the development of clinical study protocol synopses and full protocols
Lead the development of investigator brochures
Contribute in the writing and review of clinical study reports (csrs), data safety update reports (dsurs) and annual reports and regulatory briefing books
Manage development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data
Participate in publication planning
Contribute towards writing of departmental working processes (sops, templates, etc)
Clinical study planning
Assist clinical research physician in developing clinical development plans
Contribute to the development of data collection tools, statistical analysis plans (saps), case report forms (crfs)
Review of scientific literature
Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied
Identify and review literature that addresses specific topics of interest relevant to arvinas drug candidates
Qualifications
Advanced, doctoral level degree preferred such as phd, md, msc/mph, pharmd, with 5+ years of experience within a pharmaceutical company environment requiredBs/ ms with equivalent relevant working experience may be considered.
Oncology/ neurology disease experience preferred
Basic knowledge of gcp/ich, drug development process, study design, statistics, and experience in conducting clinical trials required
Excellent project management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
Passionate commitment and a strong team player
Understands the impact of decisions and can function successfully across a variety of projects, and manage change in a dynamic environment
Proven expertise in the proactive identification of issues, coupled with the ability to contribute to solutions affecting cross-functional teams
Demonstrated ability to work independently, as well as equally able to take direction/instruction from others and reliably deliver objectives of high quality in a timely manner
#li-remote
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their familiesBenefits include group medical, vision and dental coverage, group and supplemental life insurance, and much moreTo learn more about arvinas, please visit www.arvinas.com
Arvinas is an equal opportunity employer
