Clinical Scientist

Clinical Development     ·      New Haven, CT       ·      Full time

Full Job Description

Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments 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 350 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They 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 treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.

Position Summary

The Clinical Scientist is responsible for providing scientific support for all Global Clinical Development activities. This 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 input. This 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 company. The 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 company. Working 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 required. BS/ 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 families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an Equal Opportunity employer

Please click here to apply.