Open Positions: Clinical Trial Leader
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrateresistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
Arvinas is a fast-paced, team based, innovative organization creating products to benefit patients’ health. As a member of the Arvinas team you will be challenged to deliver life changing therapies for patients whose lives have been impacted by cancer and other acute diseases.
The Clinical Trial Leader provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong external vendor and CRO management skills are critical for this role. The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
This position is based out of our headquarters in New Haven, CT or may be performed remotely from a location within the U.S.
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 trial
- 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 Lead 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 trial coordination experience in a clinical research environment
- Bachelor’s in a clinical or science-based subject
- 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
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.