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 Planning Specialist supports study teams’ efforts to plan and execute clinical trials. Working at the direction of the Clinical Trial Leaders, the Planning Specialist will develop study level timelines by integrating cross-functional milestones and metrics. The Specialist will monitor milestones and model timeline changes for the team. She/he is responsible for driving the adoption of a clinical trial planning capability and operating model to support Study Teams and cross-functional, study-level project planning and management and develop/update management reports.
This position reports to the Clinical Operations Logistics Lead 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:
- Develop/maintain detailed clinical trial execution plans (phase I-III) for Clinical Operations starting with portfolio and asset governance support and managed through CSR finalization.
- Conduct critical path analyses to drive optimization of trial planning, country allocation & feasibility, assess risks to trial delivery
- Partner within the Clinical Study Team to monitor delivery of clinical study milestones.
- Identify gaps and risks in the study plans and collaborate to proactively develop solutions which will increase efficiency and minimize timelines.
- Document key decisions, risks, mitigations, resolution and escalation of issues
- Develop and manage Leadership status reports and updates
- Monitor overall study health and ensure risks and issues are evaluated and appropriately captured in systems and tools as needed
- Provide regular study status reports to key Clinical Operations, Study Team and governance stakeholders consistent with established processes and best practices
- Collaborate with Project management to integrate study milestones into Program level timelines
- 5+ years of strong hands-on experience supporting clinical trial planning.
- Demonstrated expertise in MS excel and project planning software such as Microsoft Project, SmartSheet, Asana, etc.
- Ability to coordinate, collate and integrate plans across multiple functions within the Clinical Development organization.
- Oncology/rare disease experience preferred or multi-therapeutic clinical planning experience
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Effective communication and interpersonal skills; effective interaction with cross functional team members.
- Bachelor’s degree in Life Sciences, Operations Management, or Engineering required.
- PMP certification a plus.
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