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.
The Clinical Trial Leader provides clinical trial oversight to assigned early Clinical Pharmacology trials ensuring deliverables are met in terms of quality, compliance and timing. Strong external vendor and CRO management skills are critical for this role and this role is accountable for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
This position reports to a Director, Clinical Operations and can be remote, hybrid, or located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Day to day management of assigned clinical trial to ensure deliverables are met in all phases of the assigned trial(s).
- Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives.
- Communication to internal team members on deliverables.
- Coordinate clinical study timelines with Project management to meet critical milestones and escalate issues that may jeopardize timelines and deliverables.
- Proactively assess potential risks to the study and propose mitigation plans.
- Ensure set-up and implementation of effective investigator and site monitor training.
- Provide oversight and direction to study team members, including vendors, for study deliverables.
- Manage trial feasibility and site selection process.
- Work closely with study Clinical Operations Leads to execute clinical studies.
- Participate in the review, development and/or writing of clinical trial documents and manuals, such as protocol, informed consent form and site materials including training, manuals and support documentation.
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
- Periodic review of clinical data
- Review of clinical monitoring reports to ensure timely completion and identification of issues.
- Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables.
- Maintain trial metrics.
- Ensure trial is conducted in accordance to and ICH/GCP standards including multiple regions in global trials
- Support testing clinical trial systems/databases (i.e. UAT)
- Develop and maintain strong, collaborative relationships with key stakeholders.
- At least 5-10 years of related clinical trial coordination experience in a clinical research environment
- Breast/Prostate cancer trial experience preferred.
- Relevant experience in global setting managing CROs and vendors
- Solid understanding of drug development
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Bachelor’s degree in a clinical or science-based subject
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