Laboratory Operations Specialist

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 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 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

As a member of the Clinical Operations Team, the Laboratory Operations Specialist is responsible for overseeing all operational aspects of outsourced clinical, biomarker safety and DMPK studies associated with the drug candidates in the Company’s pipeline, and helping to manage, review and develop external laboratory budgets.

This position reports to the Executive Director, Clinical Operations and will be located at our headquarters in New Haven, CT or may be performed from a remote location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Managing CRO partnerships relative to laboratory support of the clinical safety, DMPK, bioanalytical, pathology in clinical trials on an ongoing basis
• Review and approved laboratory manuals
• Work with CROs, logistics vendors and laboratories to ensure appropriate lab kits and supplies are available at sire at the appropriate times
• Provide oversight and/or Management of clinical supplies for studies
• Managing the support of operations for the Company’s development programs to include coordination of internal subject matter experts and consultants to support the planning and implementation of external clinical, clinical safety and DMPK studies with associated bioanalysis laboratories to support of the company’s clinical candidates in clinical trials with appropriate cost, timing and risk assessment
• Manage oversight of specimen handling for all types of laboratory analyses.
• Leads the development of internal policies and procedures to optimize management of high-quality clinical, clinical safety, biomarker and DMPK studies
• Managing laboratory analytical timelines, ensuring delivery of key data, and reporting deliverables in order to meet NDA filing goals and project team objectives
• Ensure external data is delivered by CROs and laboratories according to contracted timelines and reviewed by appropriate Subject Matter Experts in a timely manner
• Partnering with external consultants, operational counterparts, and CROs to coordinate and facilitate audits, study logistics/schedules/deliverables, and financial workflows
• Track and manage sample logistics for bioanalytical, clinical safety, and DMPK studies for multiple programs managed through partner CROs and ensures contracted timelines are followed, in collaboration with the scientific leads
• Supports departmental budgetary operations by coordinating with Finance to develop, track, and manage budgets for laboratory activities and identify budgetary impacts of strategic decisions.
• Initiating, negotiating, and managing contracts for laboratory support of bioanalytical, clinical, biomarker safety and DMPK studies
• Collaborate closely with research teams and project teams, directly contribute to and represent clinical operations on internal and external project teams
• Facilitate open communication across departments and functions

Qualifications

• Possess a solid understanding of clinical trials, GCP regulations, and CRO landscape
• Demonstrated track record of managing relationships with vendors, suppliers, and contract organizations effectively
• Excellent communication skills, including the ability to influence cross-functionally and articulate complex issues clearly to drive understanding and decision-making
• Experience reviewing and analyzing budgets and long-range planning encompassing all areas of laboratory support for clinical trials.

Education

• Bachelor's degree in life science or quality-related field and at least 5 years of experience in clinical trial management of a laboratory(ies).

#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